Comparative study between two treatment regimens of Cisplatin-5-Fluorouracil and Gemcitabine-Cisplatin in gallbladder cancer patients

The research study was designed to compare the safety and efficacy of the regimen of 5-flurouracil with cisplatin of investigational arm with the reference regimen of gemcitabine with cisplatin for the treatment of gallbladder cancer. A total of 60 patients were enrolled in the study. Out of 30 patients enrolled in arm-A (Gemcitabine with Cisplatin) and 30 patients enrolled in arm-B (5-Flurouracil with Cisplatin) for safety assessment. For the efficacy evaluation total of 16 patients enrolled which is equally divided in both arm. Total 150 cycles of chemotherapy were given to each arm of patients. Both arms were well balanced with respect to age, stage of disease and measurability. The overall response rate (ORR) was 62.5% in arm-A compared to 50% in arm-B (p=0.34). Whereas 95% confidence interval (CI) for the efficacy was found 46.25-8.74% vs 32.67-67.32% between arm-A and arm-B. The most prevalent toxicities were found anemia (p