SPARC: SBRT pre-operatively for pancreatic cancer
Research type
Research Study
Full title
A Phase I trial of preoperative, margin intensive, stereotactic body radiation therapy for pancreatic cancer
IRAS ID
151294
Contact name
Maria Hawkins
Contact email
Sponsor organisation
University of Oxford Clinical Trials & Research Governance
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 2 days
Research summary
In 2010, 8,463 people in the UK were diagnosed with pancreatic cancer and there were 7,901 deaths. In 2005-2009, 5yr overall survival is 4%. Only 20% of patients are amenable to surgery. Even in resected patients receiving optimum adjuvant chemotherapy, median survival is 24 months. Standard therapy for patients with borderline resectable pancreatic cancer in Europe is upfront surgery then adjuvant chemotherapy. The role of neoadjuvant radiotherapy in pancreatic cancer has been rarely addressed.
One of the significant challenges is to improve outcome post-surgery by achieving clear resection margins. Positive margins have been reported in >35% of patients in the largest adjuvant trial in pancreatic cancer. Patients with positive margins have poor outcome.
The use of pre-operative RT/CRT is considered standard in some tumours where it has been shown to reduce risk of local recurrence and prolong survival. Its role in pancreas is less clear, possibly because pancreatic tumours are more radio-resistant.
Stereotactic body radiation therapy (SBRT) is a technique where an ablative dose of RT is delivered to a small volume targeting the surgical margin in a short time, achieving higher dose than conventionally fractionated RT. The short delivery and minimal acute toxicity makes this an attractive treatment option.
This study aims to test the safety and benefit of pre-operative SBRT. We propose 5 fractions to decrease the risk of late normal tissue injury.
The non-interventional phase of follow-up at the end of study will also allow us to estimate the efficacy of pre-operative SBRT on overall survival and progression free survival.
We will recruit up to 24 patients from 3 UK centres. Eligible patients will receive 5 fractions of stereotactic radiotherapy over 5-8 days, and surgery will take place 5-6 weeks after radiotherapy. Patients will be on the study for 36 weeks.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0059
Date of REC Opinion
20 Mar 2015
REC opinion
Further Information Favourable Opinion