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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01013805
Registration number
NCT01013805
Ethics application status
Date submitted
8/10/2009
Date registered
16/11/2009
Date last updated
12/07/2017
Titles & IDs
Public title
Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer
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Scientific title
A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer
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Secondary ID [1]
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ACTRN12610000175077
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Secondary ID [2]
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TROG 09.01
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Universal Trial Number (UTN)
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Trial acronym
PROArCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rectal Cancer
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Condition category
Condition code
Cancer
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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
Treatment: Other - External Beam Radiotherapy
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Surgery - Surgical Resection
Experimental: Arm 1 - Integrated Preoperative Radiotherapy (external beam radiotherapy) and Chemotherapy (Oxaliplatin, Fluorouracil and Leucovorin), then surgical resection.
Treatment: Other: External Beam Radiotherapy
Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy.
Weeks 8-10: as per Weeks 3-5
Treatment: Drugs: Oxaliplatin
Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU).
Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1.
Treatment: Drugs: Fluorouracil
Week 1: (after Oxaliplatin and leucovorin)5-FU 400mg/m2 bolus Day 1, then 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1.
Weeks 3 to 5: radiotherapy 25.2 Gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-FU 200 mg/m2/day on the days of radiotherapy Week 6: as per Week 1, Weeks 8-10: as per Weeks 3-5 Weeks 11: as per Week 1.
Leucovorin 200 mg/m2 Day 1 concurrent with Oxaliplatin over 2 hrs, then 2nd: 5-FU 400 mg/m2 bolus Day 1, then 3rd: 5-FU continuous infusion 2.4 g/m2 over 46 hours from Day 1
Treatment: Drugs: Leucovorin
Week 1: Oxaliplatin 100 mg/m2 Day 1 (over 2 hours), leucovorin 200mg/m2 Day 1 concurrent with oxaliplatin over 2 hrs (then 5-FU) Week 6: as per Week 1, Weeks 11: as per Week 1.
Treatment: Surgery: Surgical Resection
Surgery is to be performed according to the standard procedure for locally advanced rectal cancer 4 to 6 weeks after completion of the integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen
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Assessment method [1]
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Timepoint [1]
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End of preoperative treatment (11 weeks)
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Secondary outcome [1]
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Complete pathologic response rate following the completion of treatment
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Assessment method [1]
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Timepoint [1]
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Determined post-surgery
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Secondary outcome [2]
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Treatment Related Toxicity rates
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Assessment method [2]
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Timepoint [2]
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Determined after preoperative treatment and 30 days post-surgery
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Secondary outcome [3]
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Dose Intensity of the treatment drug
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Assessment method [3]
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Timepoint [3]
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End of preoperative treatment (11 weeks)
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Eligibility
Key inclusion criteria
- Previously untreated and pathologically proven adenocarcinoma of the rectum.
- MRI staged T3 or T4, any N.
- Lower border of tumour must be within 12 cm of anal verge.
- Age greater than or equal to 18 years.
- ECOG Performance Status 0-1 (Appendix 2)
- Absolute neutrophil count greater than or equal to 1.5 x 109/L, haemoglobin greater
than or equal to 90 g/L, and platelets greater than or equal to 100 x 109/L.
- Adequate renal function: GFR greater than or equal to 55 mL/min (derived from serum
creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic
techniques).
- Bilirubin and ALT less than or equal to 1.5 x upper limit of normal.
- No symptomatic peripheral neuropathy greater than or equal to grade 2.
- Male or non-pregnant, non-lactating female. Patients on study with reproductive
potential, or female partners with reproductive potential, must use an effective
contraceptive.
- Has provided written informed consent for participation in this trial
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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
- Presence of metastatic disease.
- Prior pelvic radiotherapy
- Febrile intercurrent illness or infection.
- Previous history of unstable angina
- Cardiac arrhythmia which in the opinion of the investigator would compromise the safe
delivery of protocol treatment
- Acute coronary syndrome even if controlled with medication
- Myocardial infarction within the last 12 months
- Concurrent treatment with other anti-cancer therapy.
- Significant medical condition which in the opinion of the investigator would
compromise the planned delivery of the chemotherapy and radiotherapy or which may be
potentially exacerbated by these modalities.
- Locally recurrent rectal cancer.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2012
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Sample size
Target
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Accrual to date
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Final
41
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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8006 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Trans Tasman Radiation Oncology Group
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aims of the trial are (1) to determine the tolerability rate in the setting of a
multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and
complete pathologic response rate in patients with locally advanced rectal cancer who are
treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01013805
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sam Ngan
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Address
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Trans Tasman Radiation Oncology Group
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01013805
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