Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer (PORTICO-SABR)

CCTU- Cancer Theme

Status

Unknown

Conditions

Cancer of Pancreas

Treatments

Radiation: Pre-operative stereotactic ablative body radiotherapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04128332

PORTICO-SABR

Details and patient eligibility

About

A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.

Full description

This is a single-centre, prospective, non-randomised feasibility study. This study will assess whether SABR can safely be given immediately prior to Whipple's resection by assessing the rate of post-operative complications.

Enrollment

10 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Stage 1:

Have given written informed consent to participate in stage 1
Be aged 16 years or over at the time of signing the informed consent form
Presence of a hypodense pancreatic mass on contrast enhanced CT scan highly suspicious of operable primary pancreatic cancer as assessed by a pancreatic multi-disciplinary team (MDT)
Have not had pre-operative systemic therapy or radiotherapy

Inclusion Criteria Stage 2:

Have participated in stage 1 of the study
Have confirmed histological or cytological diagnosis of primary pancreatic adenocarcinoma OR radiological evidence of pancreatic head mass with supportive cytological or histological findings.
Be scheduled to undergo pancreatico-duodenectomy (Whipple's) resection.
Written informed consent to participate in stage 2
Aged 16 years or over at the time of signing informed consent
Have not had pre-operative systemic therapy or radiotherapy
ECOG Performance status 0-1
Adequate renal function: GFR ≥ 60

Exclusion Criteria:

Any condition or abnormalities that in the judgement of the investigator/surgeon/clinical oncologist would place the patient at undue risk
Women who are known to be pregnant
Previous abdominal radiotherapy
Women of child-bearing potential who are unwilling to use 2 highly effective forms of contraception during the study treatment period