Health Condition 1: K87- Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere
Conditions
Interventions
Intervention1: irinotecan versus oxaliplatin / 5-FU based chemotherapy (mFOLFOX/CAPOX): open-label prospective non-inferiority study of
irinotecan versus oxaliplatin / 5-FU based chemotherapy (mFOLFOX
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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 ââ?¬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 ââ?°Â¥ 1.5 x 109/L, platelets ââ?°Â¥ 100 x109/L.Liver functions- bilirubin ââ?°Â¤ 2 x upper limit normal (ULN), AST/ALT ââ?°Â¤ 5 x ULN, S. albumin ââ?°Â¥ 28 g/L . Renal function- Creatinine ââ?°Â¤ 1.5 ULN, Creatinine clearance ââ?°Â¥ 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 ââ?°Â¥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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with advanced BTC are a fragile cohort of patients who need optimal sequencing of therapy to maximize outcomes. Additionally, BTC is near-endemic cancer in certain parts of India and we need to identify optimal treatment approaches in such patients. In patients who have progressed on first-line therapy, there needs to be an optimized approach to sequencing therapy to achieve a balance between responses and survival on one side and therapy-related toxicities on the other.Timepoint: at baseline , at 8-12 weeks and then 2- 3 months post starting treatment . | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the efficacy of irinotecan vs mFOLFOX/CAPOX as second-line therapy in advanced/ metastatic biliary tract cancers in terms of Progression-free survival (PFS).To estimate the efficacy of irinotecan vs mFOLFOX/CAPOX as second-line therapy in advanced/ metastatic biliary tract cancers in terms of Overall response rate (ORR).To estimate the efficacy of irinotecan vs mFOLFOX/CAPOX as second-line therapy in advanced/ metastatic biliary tract cancers in terms of decrease in CA 19-9 serum levels.To estimate the safety of irinotecan vs mFOLFOX/CAPOX as second-line therapy in advanced/ metastatic biliary tract cancers in terms of grade 3/4 toxicity as per CTCAE v5.0. Timepoint: at baseline , at 8-12 weeks and then 2 - 3 months post starting of the treatment . | — |
Countries
India
Contacts
Public ContactDr Prabhat Bhargava
tata memorial Hospital
Outcome results
None listed