Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.
This is a prospective, pragmatic and multi-centre clinical trial, without blinding or
masking to the randomly assigned treatment. Patient registration and randomization are
centralized. There are two arms to the study, expecting an equal numbers of patients
randomized to each arm. Stratification will by according to: (1) treating
institution/country, and (2) baseline Stage (M1 = distant metastases versus M0 = no distant
metastases). The primary statistical analysis will be conducted as an "intention-to-treat"
A cost-effectiveness analysis is not required because the main contrast is between 5 and 10
fractions of EBRT, where 5 fractions are less expensive than 10 fractions. This protocol
follows the recommendations of CONSORT for the reporting of non-inferiority and equivalence
trials. The active control is 30 Gy in 10 fractions, and the new therapy is 20 Gy in 5
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Eduardo Rosenblatt, MD
International Atomic Energy Agency
United Nations: International Atomic Energy Agency