A clinical trial of two conceptually different radical radiotherapy treatments in stage III carcinoma of the cervix.

Two hundred and ninety-six consecutive patients under the age of 70 years and having Stage III carcinoma of the cervix were randomised to receive one of two radical radiotherapy techniques. The first was a small-field, wedged, inhomogeneous 3-week X-ray treatment, followed by two radical radium insertions delivering 80% of a radical intracavity dose. The second was a 4-week homogeneous, large-field X-ray technique, supplemented by a single intracavitary insertion giving 50% of a radical intracavitary dose. Mature 5-year survival rates for the two techniques were 38.6% and 40.3% respectively (p = 0.76). Corrected 5-year results were 44.5% and 45% (p = 0.8). The time to pelvic recurrence and the sites of pelvic recurrence were not significantly different. The rate of major morbidity was eight out of 148 in the first group and five out of 148 in the second. This large, prospective, randomised trial failed to identify any significant advantage to two conceptually different techniques which explored different volumes, fractionation and balance between X-ray therapy and intracavitary therapy. The overall results remain very satisfactory when compared with recently published European results.

RCT Entities:   Population Interventions Outcomes