An MRC prospective randomised trial of radiotherapy versus surgery for operable squamous cell carcinoma of the oesophagus.

The objective of the trial was to determine whether there was any difference in survival rates after operable cases of squamous cell carcinoma of the oesophagus were treated by radiotherapy or surgery. It was designed as a prospective, randomised, multicentre trial in the United Kingdom, after staging as potentially operable, and it was planned to enter 100 patients per annum for 4 years, with a minimum follow-up of 5 years, after pre-entry staging of patients under 75 years of age by barium swallow, chest radiographs, oesophagoscopy, biopsy, bronchoscopy and CT scanning. The protocol was published in July 1986; the trial started in January 1987 and was stopped in June 1988 when only 31 patients from 16 centres were entered, although 30 centres had ethical committees' approval and were willing to start the trial. Interventions were to be as follows: 1. Surgery. According to the practice of that particular surgeon and classified as (a) curative resection if the surgeon considered that no macroscopic tumour was left behind, and (b) palliative if incompletely resected. 2. Radiotherapy. (a) Prescribed minimum corrected tumour dose of 5000 cGy with daily dose of 250 cGy in 20 fractions over 4 weeks. (b) Prescribed minimum corrected tumour dose of 6000 cGy with daily dose of 200 cGy in 30 fractions over 6 weeks. The endpoint was to be survival at 1, 2 and 5 years. The trial was discontinued after 18 months because of lack of recruitment and thus the question whether operable squamous cell cancer of the oesophagus, staged before treatment with CT scanning, is to be treated by radiotherapy or surgical resection remains unanswered. It is unlikely that a phase III trial will ever have sufficient support from surgeons to find the answer.

RCT Entities:   Population Interventions Outcomes