A study to compare the efficacy of Gemcitabine and Capecitabine in metastatic locally advanceed Gall Bladder Cancer
Phase 3
- Conditions
- Health Condition 1: C23- Malignant neoplasm of gallbladder
- Registration Number
- CTRI/2019/05/019005
- Lead Sponsor
- DR B BOROOAH CANCER INSTITUTE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
ECOG performance score more than equals to 2.
Written informed consent
Staging done prior to randomization.
Creatinine levels indicating renal clearance more than or equals to 50 ml/min.
Bilirubin less than 3 times of upper normal limit.
Biopsy/FNAC proven Gall Bladder adenocarcinoma
Locally advanced unresectable tumours or Metastatic disease.
Exclusion Criteria
Recurrent gall bladder cancer.
Inability to give informed consent.
Previous history of hepatobiliary cancers
Medical comorbidities precluding use of chemotherapy.
Concomitant malignancies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare progression free survival and overall survival in both chemotherapy groups.Timepoint: 1 year after completing recruitment
- Secondary Outcome Measures
Name Time Method To compare the toxicity profile and rate of completion of planned number of chemotherapy cycles (i.e. compliance) between the two groupsTimepoint: during treatment and on follow up.