A two-arm randomized phase III, open-label prospective non-inferiority study ofirinotecan versus oxaliplatin or 5-FU based chemotherapy mFOLFOX or CAPOX forpatients with locally advanced/ metastatic biliary tract cancers BTC previouslytreated with gemcitabine-cisplatin based chemotherapy.
- Conditions
- Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
- Registration Number
- CTRI/2022/01/039568
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Histologically or cytologically confirmed adenocarcinoma of the biliary tract.Either locally advanced (unresectable) / Metastatic disease that is not amenable to curative intent therapy.Patients should have been treated with palliative intent first-line Gemcitabine-based
chemotherapy and should have progressed on the same or stopped 1st line chemotherapy due to poor tolerance, adverse events, or other reasons . If the patient has been treated with curative intent Gemcitabine based therapy, this therapy should have been completed not more than 6 months before trial enrolment. ECOG performance status 0 â?? 2 . Patients who can give informed consent for the study.The patient does not have any contraindications to receive chemotherapy drugs
(5-Fluorouracil/ Leucovorin/ Capecitabine/ Oxaliplatin/ irinotecan) . Haematological- Hb > 80 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x109/L.Liver functions- bilirubin <= 2 x upper limit normal (ULN), AST/ALT <= 5 x ULN, S. albumin >= 28 g/L . Renal function- Creatinine <= 1.5 ULN, Creatinine clearance >= 40 mL/min.Women of childbearing age must have a negative pregnancy test before study entry and be using adequate abstinence. This must be continued for 6 months after completion of chemotherapy unless childbearing potential has been terminated by
surgery/radical radiotherapy . .Men must be willing to use adequate abstinence during chemotherapy and until 6 months after chemotherapy.Age >=18 years and life expectancy >3 months..Adequate biliary drainage, with no evidence of ongoing infection (patients on
maintenance antibiotics are eligible when acute sepsis has resolved) . All patients must be randomized and sites must ensure that patients allocated chemotherapy arm start treatment within 6 weeks of radiological progression.
Active CNS metastasis . Recent MI, NYHA Class III or IV congestive heart failure, ventricular arrhythmias, or uncontrolled blood pressure.Pregnant or breastfeeding patients.Psychological, familial, sociological, or geographical conditions that do not permit
compliance with the protocol.History of treatment with 5FU, Capecitabine, oxaliplatin, or Irinotecan.Patients with active second malignancies, apart from skin cancers and cervical
intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission, is considered acceptable.Pleural effusion or ascites that cause respiratory compromise ( > CTCAE v.5.0 Grade
2 dyspnea) [Appendix 21.3].Ongoing or active infection (bacterial, fungal, or viral; e.g. hepatitis viral ( > Grade 2 CTCAE v. 5.0), or chronic hepatitis B or C requiring treatment with antiviral therapy, or any other active liver disease.Known history of human immunodeficiency virus infection..Unresolved toxicity higher than CTCAE (v.5.0) Grade 1 attributed to any prior
therapy/procedure excluding alopecia, hypothyroidism, and cisplatin-induced
neurotoxicity <= Grade 2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method