NCT00665197

Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia

Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: International Atomic Energy Agency · Other Government
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis: In the management of advanced oesophageal cancer, to determine if a shorter regime of external beam radiotherapy (using higher daily doses, and combined with intraluminal high dose rate brachytherapy) is not inferior in the palliation of dysphagia than a more protracted course of external beam radiotherapy (using lower daily doses and combined with equal intraluminal high dose rate brachytherapy).

Detailed description

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" clinical trial. 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 fractions.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
RADIATION	Protracted Course Radiotherapy	External Beam Radiation 30 Gy in 10 fractions
RADIATION	Short Course Radiotherapy	External Beam Radiation 20 Gy in 5 fractions

Timeline

• Start date: 2007-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2008-04-23
• Last updated: 2011-10-13

Locations

7 sites across 7 countries: Canada, China, Croatia, India, Pakistan, South Africa, Thailand