Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: CHEMOTHERAPY: Treatment protocol: The modified FOLFIRINOX:
Oxaliplatin 85 mg/m2 in water with 5% dextrose intravenously (IV) over 2 hours,
Leucovorin 400 mg/m2 in normal saline IV over
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: a. Histologically proven cases of adenocarcinoma of gall bladder b. Subjects having measurable disease which is considered unresectable or metastatic c. Written consent is obtained d. ECOG Performance status e. Age >18 years f. Adequate bone marrow functions reflected as Hb ï?¾ 10gm/dl, TLC ï?¾4,000/cmm ( ANCï?¾1,500/cmm), and Platelets ï?¾1,00,000/cmm) g. Serum creatinine ï?¼ 1.8 mg% h. Serum bilirubin ï?¼3 mg% i. Liver enzymes (SGOT and SGPT) within 3 times the upper normal limit, upto 5 times in case of diffuse liver involvement j. Prior adjuvant chemotherapy/radiotherapy allowed, provided there is more than 6 months of gap between last chemotherapy/radiotherapy and recurrence k. Prior radical surgery is allowed if recurrence is unresectable
Exclusion criteria
Exclusion criteria: a. Women of reproductive age group not practicing contraception b. Lactating and pregnant women c. Patients who are on other investigational drugs d. Patient unwilling to give written informed consent e. Known history of HIV, hepatitis B or hepatitis C infection f. Symptomatic neuropathy g. Uncontrolled concurrent diabetes, hypertension or cardiac disorder
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Toxicity Resection ratesTimepoint: January 2019 to December 2019 | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Overall response rates defined as sum of complete response and partial (CR+PR) 2. Overall survival defined as date of enrollment to date of death or last seen alive Timepoint: January 2019 to December 2019 | — |
Countries
India
Contacts
Public ContactDR ATUL SHARMA
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed