Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: Chemotherapy: The effect of the mFOLFIRINOX regimen is studied in this study. i.e,
Inj. Oxaliplatin 85mg/m2
Inj. Leucovorin 400mg/m2
Inj. Irinotecan 180mg/m2
Inj. 5- Flouro-uracil 2
Sponsors
Nonfunded
Eligibility
Inclusion criteria
Inclusion criteria: All patients with diagnosis of primarily metastatic gall bladder cancer to Liver and, lymph nodal metastasis (Aorto-caval, para-aortic, Celiac) based on preoperative or intraoperative evidence without prior chemo-radio-therapy for GBC. Patients willing to give consent for being a participant in the study Patients with good performance status
Exclusion criteria
Exclusion criteria: Patients not willing to give consent. Pregnant and lactating females. History of another major cancer or previous chemo radiotherapy. Histology or cytology suggesting and alternate diagnosis other than adenocarcinoma. Gallbladder cancer with peritoneal alone metastasis, extra-hepatic biliary obstruction, extra-abdominal metastasis and metastatic incidental GBC. Patients with evidence of active infections or chronic diarrhoea. Known cases of chronic kidney disease, chronic liver disease, Congestive heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is to assess the response rate and progression free survival with mFOLFIRINOX in metastatic and unresectable gallbladder cancer.Timepoint: The response is evaluated at 6 weeks, 12 weeks. However, the progression free survival would be evaluated every three monthly after the completion of chemotherapy until the diagnosis of recurrence. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point is to assess the toxicity and overall survival after mFOLFIRINOX.Timepoint: At the end of completion of chemotherapyToxicity to the chemotherapy would be evaluated at the start of every cycle i.e every two weekly as per the CTCAE. Survival would be assessed as the time duration between the diagnosis to the final event which is death or lost to follow up. | — |
Countries
India
Contacts
Public ContactR N Naga Sathosh Irrinki
Post graduate institute of medical education and research
Outcome results
None listed