Sterotactic radiotherapy and chemotherapy to improve surgical resection and reduce recurrence

Not Applicable

Conditions: Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified

Registration Number: CTRI/2019/09/021082

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
-Median overall survival <br/ ><br> -Pathological response <br/ ><br> -Incidence of 30 day post operative complications <br/ ><br>-Radiological response per Response Evaluation by RECIST Loco-regional recurrence free survival, defined with follow-up radiological assessment.- Loco-regional recurrence free survival <br/ ><br>Timepoint: 48 months