SBRT Pre-operatively for Pancreatic Cancer — SPARC  

Pancreatic Neoplasms Clinical Trial

Official title: A Phase I Trial of Pre-operative, Margin Intensive, Stereotactic Body Radiation Therapy for Pancreatic Cancer

Status Completed

Clinical Trial Summary

In this study the investigators are testing if the addition of Stereotactic Body Radiation therapy (SBRT) prior to surgery improves surgical outcome in patients with borderline resectable or resectable pancreatic cancer (BRPC).

Clinical Trial Description

This is a single arm prospective phase I dose escalation radiation study investigating 5-fraction stereotactic radiotherapy prior to planned surgical resection in borderline resectable or resectable pancreatic cancer.

Surgical resection is the only potentially curative technique for managing pancreatic cancer. However more than 80% of patients present with disease that cannot be cured with surgical resection. Negative margin (R0 resection), tumour size, absence of lymph nodes metastases are the strongest prognostic indicators for long term survival.

Stereotactic body radiation therapy (SBRT) is a radiation technique for pancreatic cancer where an ablative dose of radiotherapy (RT) can be delivered to a small volume targeting the at risk surgical margin in a short time (1 week versus 5-6 weeks for standard radiotherapy), achieving much higher biologically equivalent dose (BED) (100Gy versus 50Gy) than conventionally fractionated radical RT. The short time of delivery and minimal acute toxicity makes this an attractive treatment option in BPRC as offers the opportunity to integrate systemic treatment. With standard fractionation schedules larger volumes of normal tissue are usually irradiated than with SBRT and an effective dose is limited by toxicity despite the use of Intensity Modulated RT.

This study builds on the current evidence base in SBRT pancreas, which has so far been largely used in the locally advanced setting with promising results and aims to take it a step further. This study aims to test the safety and benefit of pre-operative SBRT, delivering very high local doses to the at risk surgical margin which is usually around the main vessels in the retroperitoneum. The concept of margin-intensive therapy is novel, and aims to deliver a higher radiation dose while limiting toxicity to organs at risk. ;

Related Conditions & MeSH terms

• Pancreatic Neoplasms

• NCT number: NCT02308722
• Study type: Interventional
• Source: University of Oxford
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Completion date: February 2019