COMPARISON OF HEALTH RELATED QUALITY OF LIFE AND OVERALL SURVIVAL IN PATIENTS OF METASTATIC CARCINOMA GALL BLADDER RECEIVING CAPECITABINE ALONE V/S GEMCITABINE AND OXALIPLATIN

Patients with history and clinical examination suggestive of gall bladder carcinoma will be evaluated as per the NCCN guidelines 2018. Preoperatively patients will be evaluated using abdominal ultrasonography and cross sectional imaging in the form of a FDG PET CT. The staging of gall bladder carcinoma will be done according to AJCC 8th edition. All the patients with resectable Gall Bladder Cancer/locally advanced gall bladder carcinoma with feasibility for surgery will be excluded from the study.

The patients with unresectable/metastatic gall bladder carcinoma will be evaluated further with detailed history, physical examination, biochemical evaluation and necessary radiological evaluation as per the standard care. The patients with total bilirubin less than 3 mg/dl with/without biliary drainage will be included in the study. All patients with unresectable metastatic carcinoma gall bladder as per the inclusion and exclusion criteria mentioned previously will be explained regarding the trial protocol and the chemotherapy regimen that is going to be administered using patient information sheets printed in English, hindi and Punjabi. A written informed consent will be taken from all the participants of the study before randomization.

The patients will be informed about the chemotherapy regimen they are going to receive before randomization and a baseline Quality of life score using EORTC QLQ-C30 would be recorded before randomization. Patients will be randomized between two groups; one group receiving oral capecitabine as mentioned later as Group A and another group receiving injectable gemcitabine and oxaliplatin as mentioned later as Group B. A total of 6 cycles would be administered. Quality of life would be recorded at the end of every cycle. Change in quality of life score will be compared at baseline, 3rd cycle and end of chemotherapy. The response to chemotherapy would be measured using PET CT and PERCIST criteria as Complete Metabolic Response, Partial Metabolic Response, Stable Metabolic Disease, Progressive Metabolic Disease at the end of 3rd cycle, 6th cycle and 3 months after completion of chemotherapy.At the end of 3rdcycle, Patients with Progressive metabolic disease will not receive further treatment while patients with complete metabolic response, partial metabolic response and stable disease will receive further chemotherapy. The number of chemotherapy cycles tolerated would be measured and compliance to the chemotherapy would be measured at the end of every cycle.