NCT02308722

SBRT Pre-operatively for Pancreatic Cancer

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Pancreatic Neoplasms

Interventions

Type	Name	Description
RADIATION	5-fraction stereotactic body radiation therapy	The investigators expect to need a maximum of 3 dose levels investigating dose to the area at risk of involved resection lines and to the tumour bed to assess the tolerability of SBRT in this setting. Patient entry will commence at level 1. There is the option to de-escalate to Level -1 should 2 or more DLTs be observed at the starting level. SBRT will not be escalated above level 3. Level -1: Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV\_R) 8Gy/# (total dose 40Gy) Level 1: Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV\_R) 9Gy/# (total dose 45Gy) Level 2: Tumour (PTV) 6.5Gy/# (total dose 32.5Gy). Area at risk of R1 (PTV\_R) 9.5Gy/# (total dose 47.5Gy) Level 3: Tumour (PTV) 7Gy/# (total dose 35Gy). Area at risk of R1 (PTV\_R) 10Gy/# (total dose 50Gy)

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-02-01
• Completion: 2019-02-01
• First posted: 2014-12-04
• Last updated: 2021-10-07

Locations

5 sites across 1 country: United Kingdom