Health Condition 1: C269- Malignant neoplasm of ill-definedsites within the digestive system
Conditions
Interventions
Intervention1: AC-PB subtype
mFOLFIRINOX regimen: mFOLFIRINOX regimen
Oxaliplatin 65mg per m2 IV over 2 hours
Irinotecan 135mg per m2 IV over 90 mins
Leucovorin 300mg per m2 IV over 2 hours
5 FU 1800
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: -No radiological evidence of metastatic disease or and metastatic disease as discovered by on-table evaluation during definitive surgery for GBC peritoneal disease, liver metastases etc -Histologically confirmed adenocarcinoma of the ampulla post resection with the following specifications -Anatomical -Growth in the lumen or walls of the distal ends intra-ampullary component) of the common bile duct (CBD) and or pancreatic duct, or - Growth at the papilla of Vater, or -Growth at the duodenal surface of the papilla (the duodenal-facing surface of the ampullary protuberance) with the ampullary orifice clearly located within this lesion. -Stage as per AJCC 8th edition Stage II Stage III -R0/R1 resection -ECOG performance status 0 - 1 -Patient who can give informed consent for the study. -Patient does not have any contraindications to receive chemotherapy. -Duration between surgery and fitness for randomization to adjuvant therapy more than or equal to 90 days. -Adequate hematological, hepatic and renal function parameters· Hematological- Hb more than 80 g/L, ANC more than equal to 1.5 x 109/L, platelets more than equal 100 x 109/L. Liver functions bilirubin less than or equal to 2 x upper limit normal (ULN), AST ALT less than equal to 5 x ULN, S. albumin more than equal to 30 g/L, Renal function Creatinine less than equal to 1.5 ULN, Creatinine clearance more than equal to 50 mL/min. -Normal cardiac function, as assessed by echocardiography and ECG -Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial. -Written patient consent form
Exclusion criteria
Exclusion criteria: -Resected Pancreatic cancers or resected patients with doubtful epicenter of primary -R2 resections. -Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin. -Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV, -Clinically significant valvular defect -Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix -Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy, NYHA ATS G2 and above -Other severe internal disease or acute infection -Baseline neuropathy more than NCI Grade I -Chronic inflammatory bowel disease -On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study -Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether histology based intensified adjuvant chemotherapy improves 2 year recurrence free survival RFS as compared to historical controls.Timepoint: 7 year | — |
Secondary
| Measure | Time frame |
|---|---|
| -To evaluate whether histology based intensified adjuvant chemotherapy improves overall survival (OS) as compared to historical controls -Quality of life -Completion rates -Toxicity and side-effect profile in both arms Recurrence patterns Timepoint: 7 year | — |
Countries
India
Contacts
Public ContactAnant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed