Resource-Sparing Curative Treatment for Rectal Cancer
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
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
From commencement of radiation (day 1) to death or last follow-up up to 5 years.
International Atomic Energy Agency
United Nations: International Atomic Energy Agency