NCT01459328

Resource-Sparing Curative Treatment for Rectal Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: International Atomic Energy Agency · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicentre, randomized clinical trial comparing two different neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced adenocarcinoma of the rectum. This trial may establish the investigational therapy to be superior to, or at least not inferior to conventional treatment.

Detailed description

This phase III randomised clinical trial compares the outcome of two different neo-adjuvant radiation based treatments for locally advanced rectal carcinoma. This encompasses patients at risk for a positive circumfrential resection margin (CRM+) on baseline assessment imaging and pateints identified as being with a T-descriptor T4 at baseline assessment. The arms compared are as follows: * The investigational arm: short chemo-radiation course(25Gy in 5 daily fractions over 1 week) +/- surgery. * The conventional arm: protracted chemo-radiation course (50Gy in 25 daily fractions over 5 weeks combined with chemotherapy)+/- surgery. The outcomes include four domains: overall survival, biological effect, quality of life and health-related economics.

Conditions

• Rectal Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Short course radiotherapy: 25Gy in 5 daily fractions over 1 week Chemotherapy: - Bolus 5 Fluorouracil 450 mg/m2/day * Injected Leucovorin 20 mg/m2/day for 5 days
RADIATION	Radiotherapy	Conventional long course chemo-radiation: * Radiation 50Gy in 25 daily fractions over 5 weeks * Bolus 5 Fluorouracil 350mg/m2/d for 5 days * Injected Leucovorin 20mg in both the first and last (5th) week of radiation * Oral Capecitabine (CAPE) 825mg/m2 b.i.d. during the entire radiotherapy course over 5 weeks.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-09-01
• First posted: 2011-10-25
• Last updated: 2011-10-25

Locations

12 sites across 11 countries: Algeria, Brazil, Canada, Colombia, Croatia, Cuba, India, Indonesia, Italy, Slovakia, South Africa