Health Condition 1: K829- Disease of gallbladder, unspecified
Conditions
Interventions
Intervention1: 1. Oral capecitabine
: 1. Oral capecitabine will be given 1250 mg/sq. m. twice a day on days 1-14 of a 3 weekly cycle for 6 cycles.
Control Intervention1: IV Gemcitabine and oxaliplati
Sponsors
Nikesh Jaiswal
Eligibility
Inclusion criteria
Inclusion criteria: All Patients with diagnosis of primarily metastatic gall bladder cancer to Liver and, lymph nodal metastasis(Aorto-caval, para-aortic, celiac) based on preoperative or intraoperative evidence without prior chemoradiotherapy for GBC ECOG Performance status Total Bilirubin
Exclusion criteria
Exclusion criteria: Patients refusing consent for participation in study Pregnant and Lactating females History of another major cancer or previous chemoradiotherapy History or Cytology suggesting and alternate diagnosis other than adenocarcinoma Gallbladder cancer with isolated peritoneal metastasis, extrahepatic biliary obstruction, extra-abdominal metastasis and metastatic incidental GBC Patients with evidence of active infections or chronic diarrhea Known case of chronic kidney disease, chronic liver disease, congestive heart failure. Patients with poor performance score (ECOG greater than 2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Health related quality of life among patients of unresectable/metastatic carcinoma gall bladder patients receiving CAPECITABINE v/s Gemcitabine and oxaliplatinTimepoint: Baseline, at the end of 3rd cycle, at the end of 6th cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of complications among two groups(CAPECITABINE v/s Gemox) 2. Compare the tolerability in each group 3. Compare the response to chemotherapy in terms of progression free survival & overall survivalTimepoint: At baseline, at the end of 3rd cycle, at the end of 5th cycle | — |
Countries
India
Contacts
Public ContactRN SANTHOSH IRRINKI
Post Graduate Institute of Medical Education and Research
Outcome results
None listed