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Trial registered on ANZCTR
Registration number
ACTRN12614000676617
Ethics application status
Approved
Date submitted
17/06/2014
Date registered
26/06/2014
Date last updated
11/10/2022
Date data sharing statement initially provided
23/06/2021
Date results information initially provided
11/10/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Positron Emission Tomography (PET) scan in predicting response and survival in patients undergoing chemoradiation followed by surgery for oesophageal cancer
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Scientific title
A prospective, single arm, multi-centre study of post neoadjuvant chemoradiation PET as predictor of pathological response in patients with localised oesophageal cancer
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Secondary ID [1]
284789
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nil known
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Universal Trial Number (UTN)
U1111-1157-9772
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Trial acronym
CROSS PET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
oesophageal carcinoma
292163
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Condition category
Condition code
Cancer
292501
292501
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0
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Oesophageal (gullet)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All participants will receive chemotherapy consisting of carboplatin (AUC=2) and paclitaxel (50mg/m2)administered intravenously one day per week for 5 weeks. At the same time, radiotherapy will be given with a total dose of 41.4 Gy in 23 fractions, starting on the first day of the first chemotherapy cycle with 5 fractions per week over 4.5 weeks. PET scan will be performed 4 weeks after chemoradiation. Patients will be fasted for 4 hours before imaging and blood glucose level will be measured. Patients will be injected with a small amount of radioactive tracer fluorodeoxygluocose (FDG) and the PET scan will take place for about 45-90 minutes. Patients will undergo surgery 6 weeks after chemoradiation.
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Intervention code [1]
289605
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Diagnosis / Prognosis
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Intervention code [2]
289657
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Treatment: Drugs
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Intervention code [3]
289658
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Treatment: Other
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Comparator / control treatment
none
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
292382
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To assess the predictive value of the post chemoradiation PET scan with pathological response after surgical resection (volumetric PET assessment)
PET scan is performed at week 9 (4 weeks post chemoradiation) and the sensitivity, specificity, positive and negative predictive values of PET will be calculated. Whilst PET data is the primary analysis, pathological assessment obtained from surgery at week 11 (6 weeks post chemoradiation) is used to examine the correlation of PET and pathological response.
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Assessment method [1]
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Timepoint [1]
292382
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week 9 (4 weeks post chemoradiation) for PET scan
week 11 (6 weeks post chemoradiation) for surgery
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Secondary outcome [1]
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Pathological response (complete and near complete)
Assessed on the pathological specimen obtained from surgery
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Assessment method [1]
308826
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Timepoint [1]
308826
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Week 6 post chemoradiation
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Secondary outcome [2]
308828
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Complete surgical resection (clear microscopic margin)
Assessed on the pathological specimen obtained from surgery
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Assessment method [2]
308828
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Timepoint [2]
308828
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Week 6 post chemoradiation
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Secondary outcome [3]
308829
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Assessing treatment toxicity from chemoradiation (rates of adverse events)
For example,
Radiation-skin redness, fatique, temporary discomfort when swallowing, reflux symptoms
Chemotherapy-hypersensitivity reaction, low blood counts, infections
Assessed via clinical assessment and standard chemotherapy blood test
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Assessment method [3]
308829
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Timepoint [3]
308829
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Clinic visits are scheduled at baseline, weeks 1, 3, 5 of chemoradiation, week 10 (5 weeks post chemoradiation), then every 3 months from date of surgery for 12 months, and then 6 monthly thereafter for up to 2 years
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Secondary outcome [4]
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Disease free survival (disease progression or death)
Assessed via clinical assessment and ongoing follow-up
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Assessment method [4]
308830
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Timepoint [4]
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Clinic visits are scheduled at baseline, weeks 1, 3, 5 of chemoradiation, week 10 (5 weeks post chemoradiation) , then every 3 months from date of surgery for 12 months, and then 6 monthly thereafter for up to 2 years
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Secondary outcome [5]
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Overall survial
Assessed via clinical assessment and ongoing follow-up
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Assessment method [5]
308831
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Timepoint [5]
308831
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Clinic visits are scheduled at baseline, week 1, 3, 5 of chemoradiation, week 10 (5 weeks post chemoradiation), then every 3 months from date of surgery for 12 months, and then 6 monthly thereafter for up to 2 years
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Secondary outcome [6]
308832
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Quality of life before, during and after neoadjuvant chemoradiation
Measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30) and Oesophago-gastric 25 (QLQ-OG25)
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Assessment method [6]
308832
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Timepoint [6]
308832
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Quality of life questionnaires to be completed at baseline, week 1, 3, and 5 during chemoradiation, week 10 (5 weeks post chemoradiation), then every 3 months from date of surgery for 12 months, and then 6 monthly thereafter for up to 2 years
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Eligibility
Key inclusion criteria
Age greater than or equal to 18 years
Surgically resectable carcinoma of oesophagus (PET staged T1-3, N0-1, M0)
No invasion of the tracheobronchial tree
Tumour must not extend greater than 2cm into the stomach
ECOG between 0 and 2
Patients must have adequate haematological, renal, hepatic, and pulmonary functions defined as: granulocytes greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 100 x 10^9/L, total bilirubin less than or equal to 1.5 x upper normal limit, and creatinine clearance greater than or equal to 50ml/min
Non-English speaking background patient is allowed as long as interpreter service is provided during the enrolment, treatment, and follow up phase
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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
Past or current history of malignancy other than entry diagnosis
-History of another malignancy within 5 years prior to registration. Participants with curatively treated cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or superficial bladder tumours (T1a[Non-invasive tumour], and Tis[Carcinoma in situ]), or participants who have been free of other malignancies for greater than or equal to 5 years prior to enrolment are eligible for this study
Previous chemotherapy or radiotherapy
Myocardial infarct in last 6 months
Congestive heart failure or uncontrolled arrhythmia
Neurotoxicity grade greater than 1
Uncontrolled diabetes mellitus despite maximum therapy
Pregnancy, lactation or inadequate contraception
Known allergic reaction to FDG PET contrast
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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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
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Who is / are masked / blinded?
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Intervention assignment
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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
Survival endpoints were calculated from the date of enrolment. OS and DFS were estimated using the Kaplan-Meier product limit method and will be displayed using Kaplan-Meier curves and median survivals
The level of significance of a series of prognostic factors in the prediction of survival endpoints was estimated using the log-rank test statistic. Cox regression analysis provided a multivariate analysis of these endpoints with selected prognostic factors
Continuous variables will be summarized using descriptive statistics e.g. number of patients, mean, median, standard deviation, minimum and maximum. Qualitative variables will be summarized by counts and percentages. Unless otherwise stated calculation of proportions will include the missing category. Longitudinal data will be illustrated where appropriate with graphics
Descriptive statistics of baseline patient characteristics and treatment received will be presented for all eligible patients
EORTC QLQ will be described according to EORTC guidelines. A descriptive analysis of Quality of Life (QoL) data over time will be undertaken. This will include identifying the most commonly reported, and the most troublesome, symptoms and side effects. Items from the questionnaires will be derived to form numerical scales in accordance with the scoring manuals and/or scoring conventions for each instrument. The applicability of repeated measures mixed modelling to the QoL scores collected longitudinally will be investigated. Appropriate methods for dealing with missing QoL data will be detailed in the statistical analysis plan and be informed by a blinded review of the data. Under certain assumptions, mixed models provide unbiased estimates as do multiple imputation techniques. Patterns of missing data will be considered to assess potential missing data mechanisms
A descriptive analysis of the adverse events (AE) data will be prepared for study participants. The number and percentage of participants who experience AEs will be tabulated according to AE name, organ class and grade. The number and percentage of participants who experience a grade 3 or 4 AE will also be tabulated, as will the number and percentage of participants who experience any grade AE. A descriptive analysis of dose interruption and dose modification rates will also be prepared
The 95% confidence intervals will be reported wherever appropriate
A study close-out date will be determined for the time to event analyses in order to prevent bias in the reporting of results. This is generally taken to be the earliest of the dates of last contact for patients still alive and not lost to follow-up. The event times of patients lost to follow up will be censored at the close-out date if the event has not previously occurred
Statistical analyses will be performed using STATA-SE v.11.0 (StataCorp LP, College Station, TX, USA)
A samples size of at least 184 patiens will be sufficient to exclude a false negative rate of 5% or higher (lower 95% for totaol concordance >0.95). Allowing for a modest number of drop outs and patients not proceeding to surgery, a total of 200 patients will be recruited.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/08/2014
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Actual
22/08/2014
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Date of last participant enrolment
Anticipated
30/09/2023
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Actual
2/09/2021
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Date of last data collection
Anticipated
15/10/2026
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Actual
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Sample size
Target
200
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Accrual to date
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Final
69
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
2629
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St George Hospital - Kogarah
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Recruitment hospital [2]
2630
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Prince of Wales Hospital - Randwick
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Recruitment hospital [3]
2631
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Westmead Hospital - Westmead
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Recruitment hospital [4]
2632
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [5]
20945
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Icon Cancer Centre Richmond - Richmond
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Recruitment postcode(s) [1]
35761
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3121 - Richmond
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Funding & Sponsors
Funding source category [1]
289420
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Other Collaborative groups
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Name [1]
289420
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South Eastern Sydney Local Health District
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Address [1]
289420
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District Executive Unit, Level 4, The Sutherland Hospital & Community Health Service, Cnr The Kingsway & Kareena Road, CARINGBAH, NSW, 2229
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Country [1]
289420
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Australia
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Primary sponsor type
Individual
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Name
Dr Ariyanto Pramana
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Address
Radiation Oncology Queensland Cairns
Liz Plummer Cancer Care Centre
Cnr Lake and Grove Sts
Cairns QLD 4870
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Country
Australia
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Secondary sponsor category [1]
288103
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Individual
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Name [1]
288103
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Dr Yaw Chin
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Address [1]
288103
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Cancer Care Centre, St George Hospital, Gray Street, Kogarah NSW 2217
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Country [1]
288103
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291178
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South Eastern Local Health District
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Ethics committee address [1]
291178
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Room G71 East Wing, Edmund Blacket Building, Prince of Wales Hospital, Randwick NSW 2031
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Ethics committee country [1]
291178
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Australia
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Date submitted for ethics approval [1]
291178
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29/10/2013
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Approval date [1]
291178
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14/01/2014
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Ethics approval number [1]
291178
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13/220 (HREC/13/POWH/586)
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Summary
Brief summary
This phase II study aims to investigate whether PET scan performed after the completion of chemotherapy and radiation can predict response of oesophageal cancer.
Who is it for ? You may be eligible to join this study if you are aged 18 years or more, have been diagnosed with a localised oesophageal cancer, and are suitable for chemotherapy combined with radiotherapy prior to surgery.
Study details: Participants will undergo a single additional PET scan 4 weeks after the completion of chemo-radiotherapy. Approximately 2 weeks following this they will undergo surgery. Specimens obtained from surgery will be used to evaluate the predictive value of the PET scan. Participants will be scheduled to clinic visits for follow-up at 5 weeks after chemo-radiotherapy, 3 monthly for the first 12 months, and then 6 monthly thereafter until a minimum of 2 years. At each visit, apart from routine history and physical examination, participants will be asked to complete a series of short questionnaires which evaluate the health-related quality of life. This is a prospective, single arm, multi-centre study and a total of 200 participants will be recruited.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
49162
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Dr Ariyanto Pramana
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Address
49162
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Radiation Oncology Queensland Cairns
Liz Plummer Cancer Care Centre
Cnr Lake and Grove Sts
Cairns QLD 4870
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Country
49162
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Australia
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Phone
49162
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+61 7 4036 5200
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Fax
49162
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+61 7 4036 5210
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Email
49162
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[email protected]
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Contact person for public queries
Name
49163
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Mr Xiaobing Ma
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Address
49163
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Clinical Research Unit, Pitney Clinical Sciences Building, St George Hospital, Gray Street, Kogarah NSW 2217
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Country
49163
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Australia
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Phone
49163
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+61 2 9113 4059
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Fax
49163
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+ 61 2 9113 4822
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Email
49163
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[email protected]
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Contact person for scientific queries
Name
49164
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Dr Yaw Chin
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Address
49164
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Cancer Care Centre
St George Hospital, Gray St, Kogarah NSW 2217
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Country
49164
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Australia
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Phone
49164
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+61 2 9113 3916
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Fax
49164
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Email
49164
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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
Not Available
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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
No additional documents have been identified.
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