Can pure accelerated radiotherapy given as six fractions weekly be an option in locally advanced carcinoma cervix: Results of a prospective randomized phase III trial.

ABSTRACT

CONTEXT Concurrent chemoradiation is presently the standard of care in locally advanced malignancy of the cervix uteri. But accelerated radiotherapy regimes have not been investigated much. AIMS: We conducted a randomized trial to compare the results of pure accelerated radiotherapy given as six fractions weekly to standard chemoradiotherapy in locally advanced carcinoma cervix patients. SETTINGS AND DESIGN: This was a prospective, phase III trial in which 106 patients of locally advanced (stage II and III) carcinoma cervix were randomized into two arms. SUBJECTS AND METHODS: The study arm (ART) received 50 Gy accelerated radiotherapy in 25 fractions, six fractions weekly; while control (CRT) arm was treated with concurrent chemoradiation 50 Gy in 25 fractions with weekly injection cisplatin. This was followed by intracavitary brachytherapy (ICBT; total dose of 85 Gy to point A) in both the arms. Fifty-one patients completed treatment in the ART arm and 50 patients in the CRT arm. In these patients, response to treatment, toxicity, and overall survival (OS) and disease-free survival (DFS) were compared between both the arms. STATISTICAL ANALYSIS USED Survival analysis was done using Kaplan.Meier estimates, logrank test was used to compare differences, while proportions were compared using the Fisher's t-test. RESULTS: At a median follow.up of 36. months there was no difference between the two arms in terms of OS. (61 vs 62%,P = 0.9009) as well as DFS. (60 vs 64%,P = 0.6411) CONCLUSIONS: Accelerated radiotherapy given as six fractions per week is an effective alternative to concomitant chemoradiation in locally advanced carcinoma cervix and has shown lesser toxicities in our study.