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Study Objective: To compare the disease response,disease free survival,overall survival and toxicity profile to neoadjuvant chemotherapy followed by radiotherapy(CT-RT group) versus radiotherapy alone(RT alone) in locally advanced carcinoma cervix. Materials and Method:Between July 2007 and August 2008, 113 patients with squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma cervix, FIGO stage IIB-IIIB, were randomized to receive either two cycles of cisplatin and 5flourouracil(CT) followed by radiotherapy(RT) (CT-RT group ,n=58) or RT alone (RT alone group , n=55). Result & Conclusion: In the CT-RT group 54 evaluable patients 52 responded: clinical complete response(cCR) in 1(1.85%) and partial response in 51(94.45%). Remaining 2 patients (3.70%) had progressive disease (PR). Of 52 patients completed RT as planned. Following RT 38(73.08%) achieved clinical CR, 13(25%) had residual disease, and 1(1.92%) had progressed at first follow up after 1 month. The stage of disease, histological grade, had no influence on the response to CT. Nausea /vomiting were the major side effects of CT. In the RT group, 54 patients were evaluable 41(75.93%) patients achieved clinical CR, 12(22.22%) had residual disease, and 1(1.85%) progressed. The side effects of RT were lower GI toxicity (diarrhea) and local skin reaction. These were equally distributed between the two groups. After 36 months of follow up, cCR was seen in 34(64.15%) patients, PR in 8(15.09%) patients and 11(20.76%) patients had died in CT-RT group. In RT alone group 36(66.67%) patients had cCR, 8(14.82%) patients had PD and 10 (18.51%) patients had died. There were no significant difference in overall and disease free survival in the two groups.

Neoadjuvant chemotherapy followed by radiotherapy versus radiotherapy alone in locally advanced carcinoma cervix: a prospective randomized study.