CTRI/2015/09/006175Recruiting未知
Gemcitabine and oxaliplatin vs gemcitabine and capecitabine in patients with unresectable Carcinoma gall bladder with obstructive jaundice post PTBD/stenting (PTBD or ERCP). A randomized controlled study.
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- AIIMS
- Enrollment
- 104
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Patients with biopsy or cytology proven unresectable or metastatic carcinoma gall bladder with obstructive jaundice.
- •2. Limited liver or peritoneal metastases with good performance status (ECOG < 3)
- •Adequate organ and bone marrow function.
- •3. Haemoglobin more than 10 g/dl, absolute neutrophil count more than 1.5Ã?109/L, platelets higher than 100 Ã? 109/L.
- •4. Serum creatinine <1.8 mg/100 mL.
- •5. Serum bilirubin <3 mg/100 mL, liver enzymes (AST and ALT) within 3 times the normal limit (5 times in case of diffuse hepatic involvement).
- •6. Eastern Cooperative Oncology Group performance status of <3.
- •7. Prior adjuvant chemotherapy and/or radiotherapy, if given, should have been completed 6 months before enrollment
Exclusion Criteria
- •1 Diffuse metastases in the liver or disseminated disease
- •2.Gross ascites
Investigators
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