Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified
Conditions
Interventions
Intervention1: Arm B experimental Arm SBRT followed by 2 cycles of folfirinox: Patients in the experimental arm after SBRT will received 2 cycles of modified folfirino post 1 to 2 weeks of SBRT fluo
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: -Radiologically defined to be resectable as per the NCCN guidelines Version 2 on a Triphasic CECT scan amenable to oncological surgical resection. Selected ampullary adenocarcinomas involving pancreatic head or abutting or involving vessels will be included. -Patients with no evidence of regional or distant metastatic disease based on CT scan of the chest/ abdomen/pelvis -No significant co-morbidities that would interfere with treatment and fit for general anaestheia -Reliable for follow-up and signed informed consent. -Karnofsky performance status (KPS) between 70 and 100. -Patients with tumors primarily of the body or tail of the pancreas requiring a distal pancreaticoduodenectomy.
Exclusion criteria
Exclusion criteria: -Prior surgical resection of any pancreatic malignancy -Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields -History of prior allergic reactions attributed to compounds of CT or MRI contrast -Any prior therapy for pancreatic cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of margin negative resection, defined as the absence of viable tumor cells more than 1 mm from the inked surgical marginTimepoint: 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Median overall survival -Pathological response -Incidence of 30 day post operative complications -Radiological response per Response Evaluation by RECIST Loco-regional recurrence free survival, defined with follow-up radiological assessment.- Loco-regional recurrence free survival Timepoint: 48 months | — |
Countries
India
Contacts
Public ContactAkanksha Anup
Tata Memorial Hospital
Outcome results
None listed