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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
External Beam Radiation 30 Gy in 10 fractions
External Beam Radiation 20 Gy in 5 fractions
Credit Valley Hospital Statistical Centre
Credit Valley, Ontario, Canada
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
University of Zagreb Clinical Hospital
Zagreb, City of Zagreb, Croatia
Tata Memorial Hospital
Mumbai, Parel, India
Dysphagia relief
Time frame: 3 years
Quality of life
Time frame: 3 years
Treatment Toxicity
Time frame: 3 years
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Institute of Nuclear Medicine and Oncology
Lahore, Punjab Province, Pakistan
University of the Witwatersrand Department of Radiat. Oncology
Johannesburg, Parktown, South Africa
Mahidol University Faculty of Medicine Siriraj Hospital
Bangkok, Siriraj, Thailand