Comparison of two high dose rate intracavitary brachytherapy regimens in treatment of cervical cancer: a preliminary report.

BACKGROUND: To assess and compare the local control and toxicities between HDR Intracavitary Brachytherapy with 7.5 Gy and 9 Gy per fraction after EBRT in treatment of carcinoma cervix. METHODOLOGY: A total of 180 patients were randomly assigned to 2 arms. Arm A received HDR intracavitary brachytherapy with a dose of 7.5 Gy per fraction, 1 fraction per week for 3 fractions and Arm B received 9 Gy per fraction, 1 fraction per week for 2 fractions. Patients were evaluated on follow up for assessment of local control and toxicities. RESULTS: The median follow up was 12 months (6-18 months). In arm A 89% of the patient had complete response and 11% had recurrence or metastasis. In arm B 93% of the patient had complete response and 7% had recurrence or metastasis. Grade 2/3 diarrhoea was seen in 4.4% of patients in Arm A and in 7.7% in Arm B. Grade 2/3 proctitis was seen in 3.3% of patients in 7.5 Gy arm and in 6.6% in 9 Gy arm. One patient in each arm had grade 1 haematuria. The overall duration of treatment was significant lower in Arm B compared to Arm A (59 days vs 68 days, p = 0.01). CONCLUSION: The result of this clinical study shows that Intracavitary brachytherapy with a dose of 9 Gy per fraction is non inferior to other schedules in term of local control and does not result in increased toxicity.