Adenocarcinoma of Rectum Clinical Trial
Official title:
A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum
This is a multi-centre randomised trial comparing long course (LC) preoperative chemoradiation with short course (SC) preoperative radiotherapy for patients with localised T3 rectal cancer.
Objective:
- 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
Eligibility Criteria:
- 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.
Endpoints:
- Primary endpoint is local recurrence.
- Secondary endpoints are overall survival, toxicity, abdminoperineal resection rate,
quality of life.
Treatment arms:
- 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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