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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12617001566325
Ethics application status
Approved
Date submitted
8/11/2017
Date registered
21/11/2017
Date last updated
3/12/2020
Date data sharing statement initially provided
18/07/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)
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Scientific title
Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)
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Secondary ID [1]
293302
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ctDNA-08
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Universal Trial Number (UTN)
U1111-1204-7664
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Trial acronym
DYNAMIC-III
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
305386
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Condition category
Condition code
Cancer
304672
304672
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This design incorporates two separate clinical objectives; (i) non-inferiority and (ii) benefit.
This prospective multi-centre, phase II/III randomised study aims to enrol a total of 1000 stage III colon cancer patients. Patients will be randomised 1:1 to be treated according to post-op ctDNA results (Arm B: ctDNA-informed), or per standard of care (Arm A: SOC). Enrolment will be stratified by participating centre and clinical risk groups (low risk = T1-3N1; high risk = T4 and/or N2).
Patients should be screened up to 6 weeks after surgery and tumour samples will be made available in 5 working days from consent for mutation analysis. Patients will have a blood draw during week 5-6 post-op for ctDNA analysis (ctDNA-1: post-op day 32 to day 42). Clinicians are to nominate their standard of care adjuvant chemotherapy regimen (no chemotherapy, single agent fluoropyrimidine or combination fluropyrimidine plus oxaliplatin) at the time of enrolment prior to randomisation. Randomisation will occur after the post-op ctDNA blood draw and receipt of sufficient tumour tissue. Additional blood collection time-points will depend on the schedule of adjuvant chemotherapy. Formalin-fixed paraffin embedded tumour tissue and the study bloods sample will undergo ctDNA analysis at Johns Hopkins University.
In the ctDNA-informed arm (Arm B), the post-op ctDNA result will be made available to the treating clinician approx 4-5 weeks after receipt of tumour tissue. Adjuvant chemotherapy will commence after the ctDNA result becomes available or, where the treating clinician wishes to commence adjuvant treatment before the result is available, an individual patient may commence on standard of care treatment no earlier than 6 weeks post-op, and then switch to the ctDNA informed strategy as per the protocol. Patients who are "ctDNA negative" will be managed with a de-escalation adjuvant treatment strategy and those who are "ctDNA-positive" will be managed with an escalation adjuvant treatment strategy. In the standard of care arm, patients and their clinicians will be blinded to the ctDNA results and will receive adjuvant chemotherapy as per standard of care.
Patients in Arm B receiving 3 or 6 months of adjuvant chemotherapy will have blood collection for ctDNA analysis prior to and during treatment (ctDNA-2, ctDNA-2A +/- ctDNA-2B) and at the end of treatment (ctDNA-3). These results will not be routinely made available to the patients or clinicians.
For patients where standard treatment of oxaliplatin based treatment is escalated to FOLFOXIRI, this will be given for at least 6 cycles.
TREATMENT REGIMENS:
Unless otherwise specified, duration of chemotherapy (3 or 6 months) and dose modifications on treatment are at clinician's discretion.
Recommended single agent fluoropyrimidine based chemotherapy regimens include:
1. 2 weekly De Gramont (modified)
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 400mg/m2 IV (intravenous)
c) Fluorouracil 2400mg/m2 CIV (continuous intravenous) pump over 46 hours
2. Weekly modified QUASAR
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 375-450mg/m2 IV (intravenous)(dose as per institutional standard of care)
3. Weekly modified Roswell Park (weekly for 6 weeks followed by 2 week break)
a) Leucovorin 50mg IV (intravenous)
b) Fluorouracil 500mg/m2 IV (intravenous)
4. Capecitabine orally days 1 to 14, every 21 days (dose as per institutional standard of care)
Recommended combination oxaliplatin-based chemotherapy regimens include 12 or 24 weeks of:
1. 2 weekly FOLFOX6 (modified)
a) Oxaliplatin 85mg/m2 IV (intravenous)
b) Leucovorin 50mg IV (intravenous)
c) Fluorouracil 400mg/m2 IV (intravenous)
d) Fluorouracil 2400mg/m2 CIV (continuous intravenous) pump over 46 hours
2. 3 weekly CAPOX
a) Oxaliplatin 130mg/m2
b) Capecitabine 1000mg/m2 twice a day orally days 1 to 14, every 21 days
Recommended triplet chemotherapy regimen includes 12 to 24 weeks of:
1. 2 weekly FOLFOXIRI
a) Irinotecan 165mg/m2 IV (intravenous)
b) Oxaliplatin 85 mg/m2IV (intravenous)
c) Leucovorin 50mg IV (intravenous)
d) Fluorouracil 3200mg/m2 CIV (continuous intravenous) pump over 46 hours
Standard of Care Arm (Arm A)
Clinician's choice of:
- no adjuvant chemotherapy
- fluoropyrimidine chemotherapy
-combination fluoropyrimidine plus oxaliplatin chemotherapy
ctDNA-Informed Arm (Arm B)
De-escalation or escalation chemotherapy regimen will be based on clinician's chosen standard of care chemotherapy regimen prior to randomisation
Standard of care choice - no chemo
-ctDNA Negative: No adjuvant chemotherapy
-ctDNA Positive: 3 months of fluoropyrimidine alone
Standard of care choice - 6 months of fluoropyrimidine alone chemotherapy
-ctDNA Negative: No adjuvant chemotherapy or 3 months of fluoropyrimidine chemotherapy
-ctDNA Positive: 6 months of combination fluoropyrimidine plus oxaliplatin chemotherapy
Standard of care choice - 3 months of combination fluoropyrimidine plus oxaliplatin chemotherapy
-ctDNA Negative: fluoropyrimidine chemotherapy
-ctDNA Positive: 6 months of combination fluoropyrimidine plus oxaliplatin or triplet chemotherapy (FOLFOXIRI) for 6 cycles, followed by further treatment at clinician discretion.
Standard of care choice - 6 months of combination fluoropyrimidine plus oxaliplatin chemotherapy
-ctDNA Negative: fluoropyrimidine alone or 3 months of combination fluoropyrimidine plus oxaliplatin
-ctDNA Positive: triplet chemotherapy (FOLFOXIRI) for 6 cycles, followed by further treatment at clinician discretion.
Details of adjuvant chemotherapy received, including start and stop dates, dose received, dose reduction, reason for dose reduction/interruption and reason for stopping treatment will be recorded.
Interim Analysis for Futility:
Prior to completing the phase II component, futility of the observed de-escalation rate will be evaluated. After 38 patients in the ctDNA negative cohort have been enrolled and managed according to the ctDNA result, if fewer than 26 of these patients have been de-escalated then consideration will be given to either modifying the protocol or not continuing to the 100 patients in this group.
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Intervention code [1]
299561
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Early detection / Screening
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Intervention code [2]
299564
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Treatment: Drugs
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Comparator / control treatment
Standard of Care Arm (Arm A)
Clinician's choice of:
1) No adjuvant chemotherapy
2) Fluoropyrimidine chemotherapy
3) Combination fluoropyrimidine plus oxaliplatin chemotherapy
Subjects and clinicians in SOC arms will be blinded to their ctDNA results and will receive adjuvant chemotherapy as per standard of care.
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Control group
Active
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Outcomes
Primary outcome [1]
303883
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Primary Objective - To evaluate the impact of de-escalation/escalation treatment strategies as informed by post-op ctDNA analysis. The ctDNA positive and negative cohorts will be evaluated separately:
a. For ctDNA negative patients, the trial will evaluate that a de-escalation treatment strategy is non-inferior to standard of care treatment as measured by the rate of 3-year recurrence-free survival.
b. For the ctDNA positive patients, the trial will investigate if an escalation treatment strategy is superior to standard of care treatment as measured by the 24 month recurrence-free survival
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Assessment method [1]
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Timepoint [1]
303883
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Patients from all arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for recurrence. Recurrence-free survival at 3 years post randomisation is measured by the time interval between randomisation and date of first recurrence. Recurrence is defined as evidence of disease either locally or distantly. Clinical assessment, radiological work-up and histological confirmation of recurrent disease will prove the presence of recurrent disease .
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Secondary outcome [1]
340352
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To demonstrate that a ctDNA-informed adjuvant therapy approach does not compromise recurrence free survival compared to standard of care adjuvant therapy in patients with NEGATIVE post-op ctDNA.
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Assessment method [1]
340352
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Timepoint [1]
340352
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Patients from all arms will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for survival. Overall survival is measured by the time interval between randomisation and date of death from all causes.
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Secondary outcome [2]
340381
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To correlate end of treatment ctDNA results with recurrence-free and overall survival
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Assessment method [2]
340381
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Timepoint [2]
340381
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Patients who receive treatment on the ctDNA informed arm will have "on treatment" and "end of treatment" blood tests to measure their ctDNA levels at 2 to 3 defined timepoints during treatment. The timing of these tests is dependent on the treatment regimen and duration of chemotherapy. Patients will be followed up every 3 months for the first 2 years and then every 6 months for the next 3 years post surgery for recurrence.
Overall survival is measured by the time interval between randomisation and date of death from all causes.
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Secondary outcome [3]
372776
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To demonstrate an acceptable rate of de-escalation in the ctDNA-informed negative cohort.
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Assessment method [3]
372776
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Timepoint [3]
372776
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At interim analysis and end of study
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Secondary outcome [4]
372777
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To examine the proportion of patients in whom escalated chemotherapy has reversed the ctDNA status from positive to negative post completion of the escalated treatment regime in the ctDNA-informed positive cohort.
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Assessment method [4]
372777
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Timepoint [4]
372777
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At the completion of treatment for all patients randomised to the ctDNA-informed cohort which had a positive ctDNA-1 blood result and were treated with an escalated treatment regimen. The end of treatment (ctDNA-3) sample will be analysed to determine the proportion of patients where the ctDNA status switched from positive to negative following treatment.
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Secondary outcome [5]
372778
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To compare the 3-year recurrence free survival rates between ctDNA-informed adjuvant therapy (i.e treatment escalation) and standard of care adjuvant therapy approach in patients with POSITIVE post-op ctDNA.
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Assessment method [5]
372778
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Timepoint [5]
372778
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All patients who had a positive pre-treatment ctDNA blood result and have been followed up for recurrence and survival for at least 3 years.
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Secondary outcome [6]
372779
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To compare the overall survival between ctDNA-informed adjuvant therapy and standard of care adjuvant therapy approach in patients with NEGATIVE post-op ctDNA.
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Assessment method [6]
372779
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Timepoint [6]
372779
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Overall survival in patients with NEGATIVE post-op ctDNA will be assessed in both cohorts of patients at study completion.
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Secondary outcome [7]
372780
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To compare the overall survival between ctDNA-informed adjuvant therapy and standard of care adjuvant therapy approach in patients with POSITIVE post -op ctDNA.
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Assessment method [7]
372780
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Timepoint [7]
372780
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Overall survival will be assessed for all patients in both cohorts with a positive post-op ctDNA at end of study.
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Eligibility
Key inclusion criteria
1. Patients aged greater than or equal to 18 years of age
2. Subjects with curatively resected stage III (Any T, N1 or N2, M0) colon cancer
3. Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy.
4. A representative tumour sample is available for molecular testing up to 6 weeks after surgery
5. Fit for at least 3 months of fluoropyrimidine adjuvant chemotherapy
6. ECOG performance status 0-2
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ
2. Patients with multiple primary colorectal cancers
3. Inadequate organ function:
a. Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation
b. Absolute neutrophil count <1.0x109/L
c. Platelet count <75x109/L
d. Haemoglobin <80 g/L
e. Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal
4. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to Arm A (Standard of Care) or Arm B (ctDNA-informed) is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods - ie. Minimisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2 / Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The primary analysis will be according to the intention-to-treat (ITT) principal. A secondary analysis of the primary outcome will be performed according to per-protocol population.
Non-inferiority will be declared if the lower bound of the one-sided 97.5% CI for the difference in recurrence-free survival at 3 years post-randomisation is greater than or equal to the margin (=-?%), 7.5. The recurrence free survival proportion will be estimated from the Kaplan-Meier curve. This will be analysed using tests for differences between tow proportions.
ctDNA status at the completion of all treatment for ctDNA-1 positive patients will be summarised using N and percent. Differences between the SOC and ctDNA-informed arms in each cohort will be compared using the Chi-square test. The ctDNA results turn-around time will be summarised using descriptive statistics: the mean, standard deviation (SD), median, minimum, maximum and interquartile range (25th-75th percentiles). The proportion of patients completing planned study treatment will be compared using the chi-square test.
For continuous variables, appropriate multivariate regression (proportional hazards, logistic, linear) will be used, where appropriate. Categorical variables will be evaluated by using chi-squared tests.
Recurrence free survival, overall survival and other time to event endpoints (local control) will be analysed using the method of Kaplan-Meier and (where appropriate) competing risks. Exploratory analyses adjusting for prognostic factors will be performed using proportional hazards regression methods. Results will be expressed as the estimated hazard ratio with the corresponding 95% confidence interval.
For the ctDNA positive cohort, the 12 month recurrence-free survival rates (calculated using the method of Kaplan-Meier) will be compared using tests for the difference between two proportions. Other exploratory analyses will used similar methods as described above.
Subgroups
Analysis of benefit/non-inferiority will also be examined in the high and low clinical risk subgroups.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
19/10/2017
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Date of last participant enrolment
Anticipated
19/04/2022
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Actual
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Date of last data collection
Anticipated
19/04/2024
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Actual
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Sample size
Target
1000
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Accrual to date
356
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
9362
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [2]
9363
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Western Private Hospital - Footscray
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Recruitment hospital [3]
9364
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Box Hill Hospital - Box Hill
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Recruitment hospital [4]
9365
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The Northern Hospital - Epping
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Recruitment hospital [5]
9367
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Port Macquarie Base Hospital - Port Macquarie
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Recruitment hospital [6]
9368
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Wollongong Hospital - Wollongong
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Recruitment hospital [7]
9370
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
9371
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The Queen Elizabeth Hospital - Woodville
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Recruitment hospital [9]
9372
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [10]
9373
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [11]
9404
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Newcastle Private Hospital - New Lambton Heights
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Recruitment hospital [12]
14250
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Western Hospital - Footscray - Footscray
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Recruitment hospital [13]
14251
0
Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [14]
14252
0
Melbourne Private Hospital - Parkville
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Recruitment hospital [15]
14253
0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [16]
14254
0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
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Recruitment hospital [17]
14255
0
Southwest Health Care - Warrnambool - Warrnambool
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Recruitment hospital [18]
14256
0
Frankston Hospital - Frankston
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Recruitment hospital [19]
14257
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Ballarat Health Services (Base Hospital) - Ballarat Central
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Recruitment hospital [20]
14258
0
Royal Hobart Hospital - Hobart
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Recruitment hospital [21]
14259
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Lake Macquarie Private Hospital - Gateshead
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Recruitment hospital [22]
14260
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [23]
14261
0
Concord Repatriation Hospital - Concord
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Recruitment hospital [24]
14262
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Liverpool Hospital - Liverpool
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Recruitment hospital [25]
14263
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Northern Cancer Institute - St Leonards
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Recruitment hospital [26]
14264
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Goulburn Valley Health - Shepparton campus - Shepparton
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Recruitment hospital [27]
14265
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [28]
14266
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Tamworth Rural Referral Hospital - Tamworth
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Recruitment hospital [29]
14267
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Macquarie University Hospital - Macquarie Park
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Recruitment hospital [30]
14268
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Gosford Hospital - Gosford
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Recruitment hospital [31]
14269
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Wyong Public Hospital - Hamlyn Terrace
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Recruitment hospital [32]
14270
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Echuca Regional Health - Echuca
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Recruitment hospital [33]
18142
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Nepean Hospital - Kingswood
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Recruitment hospital [34]
18143
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Epworth Eastern Hospital - Box Hill
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Recruitment hospital [35]
18144
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Epworth Freemasons (Victoria Parade) - East Melbourne
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Recruitment hospital [36]
18145
0
Epworth Richmond - Richmond
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Recruitment hospital [37]
18146
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Peninsula Private Hospital - Frankston - Frankston
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Recruitment hospital [38]
18147
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Katherine Hospital - Katherine
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Recruitment hospital [39]
18148
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Royal Darwin Hospital - Tiwi
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Recruitment postcode(s) [1]
18051
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3050 - Parkville
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Recruitment postcode(s) [2]
18052
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3011 - Footscray
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Recruitment postcode(s) [3]
18053
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3128 - Box Hill
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Recruitment postcode(s) [4]
18054
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3076 - Epping
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Recruitment postcode(s) [5]
18056
0
2444 - Port Macquarie
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Recruitment postcode(s) [6]
18057
0
2500 - Wollongong
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Recruitment postcode(s) [7]
18059
0
5042 - Bedford Park
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Recruitment postcode(s) [8]
18060
0
5011 - Woodville
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Recruitment postcode(s) [9]
18061
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4029 - Herston
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Recruitment postcode(s) [10]
18062
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6150 - Murdoch
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Recruitment postcode(s) [11]
18104
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2305 - New Lambton Heights
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Recruitment postcode(s) [12]
27247
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3000 - Melbourne
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Recruitment postcode(s) [13]
27248
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3052 - Parkville
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Recruitment postcode(s) [14]
27249
0
3065 - Fitzroy
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Recruitment postcode(s) [15]
27250
0
3550 - Bendigo
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Recruitment postcode(s) [16]
27251
0
3280 - Warrnambool
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Recruitment postcode(s) [17]
27252
0
3199 - Frankston
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Recruitment postcode(s) [18]
27253
0
3350 - Ballarat Central
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Recruitment postcode(s) [19]
27254
0
7000 - Hobart
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Recruitment postcode(s) [20]
27255
0
2290 - Gateshead
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Recruitment postcode(s) [21]
27256
0
2560 - Campbelltown
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Recruitment postcode(s) [22]
27257
0
2139 - Concord
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Recruitment postcode(s) [23]
27258
0
2170 - Liverpool
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Recruitment postcode(s) [24]
27259
0
2065 - St Leonards
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Recruitment postcode(s) [25]
27260
0
3630 - Shepparton
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Recruitment postcode(s) [26]
27261
0
2485 - Tweed Heads
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Recruitment postcode(s) [27]
27262
0
2340 - Tamworth
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Recruitment postcode(s) [28]
27263
0
2109 - Macquarie Park
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Recruitment postcode(s) [29]
27264
0
2250 - Gosford
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Recruitment postcode(s) [30]
27265
0
2259 - Hamlyn Terrace
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Recruitment postcode(s) [31]
27266
0
3564 - Echuca
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Recruitment postcode(s) [32]
32139
0
2747 - Kingswood
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Recruitment postcode(s) [33]
32140
0
3128 - Box Hill
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Recruitment postcode(s) [34]
32141
0
3002 - East Melbourne
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Recruitment postcode(s) [35]
32142
0
3121 - Richmond
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Recruitment postcode(s) [36]
32143
0
3199 - Frankston
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Recruitment postcode(s) [37]
32144
0
0850 - Katherine
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Recruitment postcode(s) [38]
32145
0
0810 - Tiwi
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Recruitment outside Australia
Country [1]
9344
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New Zealand
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State/province [1]
9344
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Christchurch
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Funding & Sponsors
Funding source category [1]
297927
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Charities/Societies/Foundations
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Name [1]
297927
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Marcus Foundation
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Address [1]
297927
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1266 W. Paces Ferry Road No. 615
Atlanta, Georgia 30327
USA
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Country [1]
297927
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United States of America
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Primary sponsor type
Other Collaborative groups
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Name
Australasian Gastro-Intestinal Trials Group
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Address
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
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Country
Australia
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Secondary sponsor category [1]
296989
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Other
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Name [1]
296989
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The Walter and Eliza Hall Institute of Medical Research
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Address [1]
296989
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1G Royal Parade
Parkville
VIC 3052
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Country [1]
296989
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298973
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Melbourne Health
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Ethics committee address [1]
298973
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Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australia
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Ethics committee country [1]
298973
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Australia
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Date submitted for ethics approval [1]
298973
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30/11/2016
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Approval date [1]
298973
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22/03/2017
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Ethics approval number [1]
298973
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HREC/16/MH/388
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Ethics committee name [2]
307449
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HREC of the Northern Territory Department of Health and the Menzies School of Health Research
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Ethics committee address [2]
307449
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PO Box 41096
Casuarina NT 0811 Australia
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Ethics committee country [2]
307449
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Australia
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Date submitted for ethics approval [2]
307449
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01/10/2019
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Approval date [2]
307449
0
11/11/2019
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Ethics approval number [2]
307449
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HREC-2019-3529
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Ethics committee name [3]
307450
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Health and Disability Ethics Committees
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Ethics committee address [3]
307450
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Ministry of Health
133 Molesworth St
PO Box 5013
Wellington 6011
New Zealand
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Ethics committee country [3]
307450
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New Zealand
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Date submitted for ethics approval [3]
307450
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25/09/2018
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Approval date [3]
307450
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04/02/2019
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Ethics approval number [3]
307450
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18/NTB/159
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Summary
Brief summary
The aim of this study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer.
Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for stage III colon cancer.
Study details
All participants in this study will have a blood draw during week 5-6 post surgery for ctDNA analysis. They will then be randomly allocated to one of two treatment groups. One group will receive standard of care treatment as selected by their clinician: either no chemotherapy, single agent fluoropyrimidine chemotherapy or combination fluoropyrimidine plus oxaliplatin chemotherapy. Treatment selection in the other group will be informed by ctDNA blood test results.
All patients will be followed up every 3 months for 2 years, then every 6 months for 3 years in order to evaluate treatment safety and efficacy. Follow-up involves additional blood tests and radiological assessments. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision regarding adjuvant chemotherapy is not inferior to standard of care in terms of recurrence-free survival.
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Trial website
none
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Trial related presentations / publications
none
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Jeanne Tie
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Address
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The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
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Country
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Australia
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Phone
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+61 3 9345 2707
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Fax
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+61 3 9498 2010
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Marlyse Debrincat
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Address
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The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
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Country
78851
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Australia
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Phone
78851
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+61 3 9345 2895
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Fax
78851
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+61 3 9498 2010
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Jeanne Tie
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Address
78852
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The Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville
VIC 3052
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Country
78852
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Australia
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Phone
78852
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+61 3 9 345 2707
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Fax
78852
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+61 3 9498 2010
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Email
78852
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
IPD may be collected at a site level. However, IPD will not be made available to the Sponsor. The data that is collected by the Sponsor will not be re-identifiable at the Sponsor level. There are safeguards in place to minimise the risk of a privacy breach. They include analysing the data on an aggregated level and access to the data in a controlled environment with only authorised study personnel. Finally, enabling the availability of IPDs will not help meet the primary and secondary objectives of the study which are dependent on the results from the study population rather than on an individual basis.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Detecting Liquid Remnants of Solid Tumors: Circulating Tumor DNA Minimal Residual Disease.
2021
https://dx.doi.org/10.1158/2159-8290.CD-21-0634
Embase
Liquid Biopsy Applications in the Clinic.
2020
https://dx.doi.org/10.1007/s40291-019-00444-8
Embase
Refining adjuvant therapy for non-metastatic colon cancer, new standards and perspectives.
2019
https://dx.doi.org/10.1016/j.ctrv.2019.02.002
Embase
Mind the target: Circulating tumour DNA in gastrointestinal malignancies.
2022
https://dx.doi.org/10.1097/CCO.0000000000000846
Embase
Circulating tumor DNA in early-stage colon cancer: ready for prime time or needing refinement?.
2022
https://dx.doi.org/10.1177/17588359221143975
Embase
Patterns of Patient-Reported Chemotherapy-Induced Peripheral Neuropathy in Colorectal Cancer Survivors.
2022
https://dx.doi.org/10.6004/jnccn.2022.7050
Embase
Current Applications of Liquid Biopsy in Gastrointestinal Cancer Disease-From Early Cancer Detection to Individualized Cancer Treatment.
2023
https://dx.doi.org/10.3390/cancers15071924
Dimensions AI
The Future of ctDNA-Defined Minimal Residual Disease: Personalizing Adjuvant Therapy in Colorectal Cancer
2022
https://doi.org/10.1016/j.clcc.2022.03.004
Dimensions AI
Advantages and Challenges of Using ctDNA NGS to Assess the Presence of Minimal Residual Disease (MRD) in Solid Tumors
2021
https://doi.org/10.3390/cancers13225698
Dimensions AI
Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer
2019
https://doi.org/10.1001/jamaoncol.2019.3616
Dimensions AI
Evaluation of Comparative Surveillance Strategies of Circulating Tumor DNA, Imaging, and Carcinoembryonic Antigen Levels in Patients With Resected Colorectal Cancer
2022
https://doi.org/10.1001/jamanetworkopen.2022.1093
Dimensions AI
Circulating Tumour DNA to Guide Treatment of Gastrointestinal Malignancies
2020
https://doi.org/10.1159/000509657
Dimensions AI
Postoperative circulating tumor DNA as markers of recurrence risk in stages II to III colorectal cancer
2021
https://doi.org/10.1186/s13045-021-01089-z
Dimensions AI
Utilizing Plasma Circulating Tumor DNA Sequencing for Precision Medicine in the Management of Solid Cancers
2023
https://doi.org/10.4143/crt.2023.446
Dimensions AI
Liquid Biopsy: From Discovery to Clinical Application
2021
https://doi.org/10.1158/2159-8290.cd-20-1311
Dimensions AI
Circulating Tumor DNA Analysis in Colorectal Cancer: From Dream to Reality
2019
https://doi.org/10.1200/po.18.00397
Dimensions AI
Clinical Applications of Minimal Residual Disease Assessments by Tumor-Informed and Tumor-Uninformed Circulating Tumor DNA in Colorectal Cancer
2021
https://doi.org/10.3390/cancers13184547
Dimensions AI
The potential role of minimal/molecular residual disease in colorectal cancer: curative surgery, radiotherapy and beyond
2023
https://doi.org/10.1016/j.jncc.2023.05.005
N.B. These documents automatically identified may not have been verified by the study sponsor.
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