drugset / Trial / NCT00193739

Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

NCT00193739 ↗

Phase 3 Unknown 635 enrolled Tata Memorial Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.

Timeline

Start
2003-09-04
Primary completion
2020-07-31
Completion
2020-07-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule — —
Comparator Cisplatin Other / unclassified — —
Comparator Paclitaxel Small molecule — —

Indications