Cervix Carcinoma Recurrent Clinical Trial
Official title:
An Open Label Randomized Phase 2, Pilot Study to Investigate the Effectiveness of Palliative Chemotherapy in Stage IVB, Recurrent or Persistent Carcinoma Cervix
Experience with substituting carboplatin for cisplatin is limited in advanced and recurrent cervix cancer and there has been no counterpart to GOG 158, which documented therapeutic equivalency of cisplatin/paclitaxel and carboplatin/paclitaxel for treatment of ovarian cancer, performed in a cervix cancer population.
This trial will be a prospective, randomized phase II pilot study. Consecutive patients of metastatic, recurrent or refractory carcinoma cervix enrolled in gynecology clinic at IRCH, AIIMS will be taken into study after taking informed consent. Patients will be randomized into two arms. Each arm shall contain 20 patients. The patients shall receive paclitaxel and carboplatin q3wk in first arm and paclitaxel and carboplatin q1 wk in second arm. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment