Spots Global Cancer Trial Database for Resource-Sparing Curative Treatment for Rectal Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Resource-Sparing Curative Treatment for Rectal Cancer

Official Title: Resource-Sparing Curative Treatment for Rectal Cancer

Study ID: NCT01459328

Conditions

Rectal Carcinoma

Interventions

Radiotherapy

Study Description

Brief 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.