PORTICO SABR
Research type
Research Study
Full title
Pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma: A window of opportunity feasibility study
IRAS ID
259410
Contact name
Thankamma Ajithkumar
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
Pancreatic ductal adenocarcinoma (PDAC) is an unmet clinical need with a 5-year survival of <10%. It is a lethal disease that typically presents late, metastasises early and is resistant to conventional treatments such as radiation and chemotherapy. Typically, 50-70% patients present with localised disease, which is operable in 15-20%. In addition, despite apparently successful resection, ~75% of patients with relapse. Achieving a complete resection following surgery is an important prognostic factor, but is only achieved in 50-60% of patients. Therefore, innovative strategies are needed to improve local and systemic disease control and to increase the rate of complete resection in apparently operable disease.
The role of stereotactic ablative radiotherapy (SABR) in operable pancreatic cancer is not currently known. As there are no previous studies evaluating SABR immediately prior to Whipple’s resection it is essential to first determine the safety in terms of post-operative complications with this therapeutic approach. The effect of SABR on the tumour immune microenvironment in patients with PDAC is also unknown. Prior to initiating future clinical studies which combine radiotherapy with immunotherapy agents in PDAC, it is essential to gain a clearer understanding of how SABR affects the tumour immune milieu.
There are 2 stages to this study.
In stage 1 participants with a radiological diagnosis of PDAC will undergo a research tumour biopsy at the time of the diagnostic biopsy.
In stage 2 participants with a histologically/cytologically confirmed diagnosis of PDAC will receive neoadjuvant SABR followed by immediate surgery.
All participants will undergo routine and research tests and assessments.
Up to 10 evaluable participants will be recruited at 1 site, Addenbrooke's Hospital in Cambridge.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0015
Date of REC Opinion
3 Apr 2020
REC opinion
Further Information Favourable Opinion