A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
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|ClinicalTrials.gov Identifier: NCT00145769|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : August 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of Rectum||Drug: Short Course Adjuvent Chemotherapy Drug: Long Course Adjuvant Chemotherapy Radiation: Short Course Radiotherapy Radiation: Long Course Radiotherapy Drug: Concurrent Chemotherapy Procedure: Initial Surgery||Phase 3|
- The objective is, in patients with T3 clinically resectable carcinoma of the rectum, to demonstrate that the local recurrence rate in patients treated with a long course (LC) of pre-operative radiotherapy with continuous infusion 5-FU is lower than that in patients treated with a short course (SC) of pre-operative radiotherapy with early surgery
- The main eligibility criteria are that the patient has clinically resectable adenocarcinoma of the rectum, a clinical stage T3 tumour whose lower border is within 12 cm of the anal verge, and no evidence of distant metastases.
- Primary endpoint is local recurrence.
- Secondary endpoints are overall survival, toxicity, abdminoperineal resection rate, quality of life.
- SC arm: Radiotherapy (RT) 25 Gy in 5 fr in 1 week to be followed by surgery within 1 week and 6 cycles of postoperative chemotherapy 5FU/Folinic acid.
- LC arm: RT 50.4 Gy in 28 fr in 5½weeks with 5FU 225 mg/m2/day throughout the course of RT, to be followed by surgery 4-6 weeks after completion of RT. 4 cycles of adjuvant 5FU/Folinic acid will be given.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||May 2011|
Active Comparator: Short Course Radiotherapy
Short Course (SC) pre-operative radiotherapy, followed by surgery and adjuvant chemotherapy
Drug: Short Course Adjuvent Chemotherapy
Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
Radiation: Short Course Radiotherapy
25 Gy in 5 fractions over 5 days.
Active Comparator: Long Course Radiotherapy
Long Course (LC) radiotherapy delivered with concurrent chemotherapy, followed by surgery and adjuvant chemotherapy
Drug: Long Course Adjuvant Chemotherapy
Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
Radiation: Long Course Radiotherapy
50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.
Drug: Concurrent Chemotherapy
5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).
Active Comparator: Surgery
Patients will receive initial surgery followed by post-operative management according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Adjuvant therapy for rectal cancer.
Procedure: Initial Surgery
Surgery is to be performed according to the NHMRC Guidelines for the prevention, early detection and management of colorectal cancer: Elective surgery for rectal cancer
- Local recurrence [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
- Survival [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
- Toxicity [ Time Frame: Interim analyses will occur annually. ]
- Abdominoperineal resection rate. This is defined as the proportion of all patients in any arm who undergo operation by abdominalperineal resection. [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
- Quality of life [ Time Frame: Main analysis will occur at minimum 3 years follow up of all patients. (After 6 years since start of trial) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145769
|Study Chair:||Sam Ngan, FRANZCR||Peter MacCallum Cancer Centre, Australia|