NCT00145769

A Randomised Trial of Preoperative Radiotherapy for Stage T3 Adenocarcinoma of Rectum

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adenocarcinoma of Rectum

Interventions

Type	Name	Description
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
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	Short Course Radiotherapy	25 Gy in 5 fractions over 5 days.
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).
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

Timeline

• Start date: 2001-07-01
• Primary completion: 2009-06-01
• Completion: 2011-05-01
• First posted: 2005-09-05
• Last updated: 2013-08-09

Locations

34 sites across 2 countries: Australia, New Zealand