to compare the two standard treatment protocol for carcinoma of biliary tract
- Conditions
- Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified
- Registration Number
- CTRI/2023/07/054679
- Lead Sponsor
- O SPONSOR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method event free survival after 12 weeks of therapy <br/ ><br>the chemotherapy will be given at 3 weekly intervals with a standard chemotherapy regimen.Timepoint: after 12 weeks of chemotherapy
- Secondary Outcome Measures
Name Time Method safetyTimepoint: after 12 weeks of intervention