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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
326
Post operative adjuvant chemotherapy: 5FU (425mg/m2) preceded by Folinic acid (20mg/m2) delivered over 5 days for 6 monthly cycles
Post operative adjuvant 5FU (425mg/m2) preceded by folinic acid (20mg/m2) delivered over 5 days for 4 monthly cycles
25 Gy in 5 fractions over 5 days.
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)
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50.4 Gy delivered in 1.8 Gy fractions over 5 1/2 weeks.
5FU 225mg/m2/day delivered IV over continous 7 day period for the duration of radiotherapy (5 1/2 weeks).
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
The Canberra Hospital
Garran, Australian Capital Territory, Australia
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
Newcastle, New South Wales, Australia
Nepean Cancer Care Centre
Penrith, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
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