OBJECTIVE: To compare the efficacy and toxicity of pelvic radiotherapy with concomitant cisplatin plus fluorouracil versus cisplatin alone in patients with locally advanced squamous cell cervical cancer. MATERIAL AND METHOD:Twenty women with squamous cell cervical cancer were randomly assigned to receive ether standard whole pelvic radiotherapy with concurrent cisplatin and fluorouracil infusion every 4 weeks or the same radiotherapy with concurrent cisplatin every 1 week. The primary endpoint was the response rate. RESULTS: All patients in cisplatin plus fluorouracil regimen and in cisplatin regimen had complete response. In cisplatin group there was higher frequencies of adverse hematologic effects. Grade 3 or 4 neutropenia occurred in 10% of the cisplatin plus fluorouracil group and in 40% of the cisplatin group (p = 0.049). CONCLUSION: No difference was found in the response rate, but higher frequencies of hemotological adverse effects in the cisplatin group.
RCT Entities:
OBJECTIVE: To compare the efficacy and toxicity of pelvic radiotherapy with concomitant cisplatin plus fluorouracil versus cisplatin alone in patients with locally advanced squamous cell cervical cancer. MATERIAL AND METHOD: Twenty women with squamous cell cervical cancer were randomly assigned to receive ether standard whole pelvic radiotherapy with concurrent cisplatin and fluorouracil infusion every 4 weeks or the same radiotherapy with concurrent cisplatin every 1 week. The primary endpoint was the response rate. RESULTS: All patients in cisplatin plus fluorouracil regimen and in cisplatin regimen had complete response. In cisplatin group there was higher frequencies of adverse hematologic effects. Grade 3 or 4 neutropenia occurred in 10% of the cisplatin plus fluorouracil group and in 40% of the cisplatin group (p = 0.049). CONCLUSION: No difference was found in the response rate, but higher frequencies of hemotological adverse effects in the cisplatin group.