Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified
Conditions
Interventions
Intervention1: gemcitabine with oxaliplatin: gemcitabine 100mg/m2 (BSA) on day 1 and 8
oxaliplatin 1000mg/m2(BSA) on day 1
Control Intervention1: gemcitabine with cisplatin: gemcitabine 1000mg/m2(BSA
Sponsors
NO SPONSOR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. ECOG performance status 0,1,2,3 3. Histologically confirmed biliary tract cancer. 4. Radiologically confirmed unresectable or metastatic disease. 5. Patient with Haemoglobin level more than 9% 6. Patient with platelet count more than 100,000 7. Patient with serum Bilirubin level less than 5gm/dl 8. Patients with mild to moderate grade transaminitis, SGOT and SGPT level less than 3X of UNL 9. Estimated GFR more than 45 mL/min as measured by the Cockcroft-Gault method14 10. Left ventricular ejection fraction >=40% 11. Chemotherapy naïve patients
Exclusion criteria
Exclusion criteria: 1. Age less than 18 years 2. End-stage kidney disease requiring haemodialysis 3. New York Heart Association grade III or IV congestive heart failure, or history of unstable angina/ myocardial infarction within six months prior to study entry 4. Grade 2 or worse peripheral neuropathy 5. Serum SGOT/SGPT levels >5 times the upper normal limits (UNL) provided, Serum Bilirubin (Total) >3 times the UNL. 6. Any acquired immunodeficiency state 7. Presence of second malignancy 8. Pregnant or Lactating females. 9. Surgically resectable tumors 10. Active infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event free survival after 12 weeks of therapy the chemotherapy will be given at 3 weekly intervals with a standard chemotherapy regimen.Timepoint: after 12 weeks of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| safetyTimepoint: after 12 weeks of intervention | — |
Countries
India
Contacts
Public ContactDR NISHANT SINHA
AIIMS RISHIKESH
Outcome results
None listed