Pre-operative Stereotactic Ablative Body Radiotherapy Followed By Immediate Surgery For Pancreatic Cancer

Study Overview

Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer

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

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.

Cancer of Pancreas

RADIATION: Pre-operative stereotactic ablative body radiotherapy

PORTICO-SABR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-10-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-02-05
First Submitted that Met QC Criteria 2019-10-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-02-09
First Posted (ACTUAL) 2019-10-16	Results First Posted N/A	Last Verified 2021-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Stereotactic ablative radiotherapy (SABR) Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.	RADIATION: Pre-operative stereotactic ablative body radiotherapy Stereotactic ablative body radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumour, while limiting the dose to the surrounding tissues.

Participant Group/Arm

Intervention/Treatment

OTHER: Stereotactic ablative radiotherapy (SABR)

Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.

RADIATION: Pre-operative stereotactic ablative body radiotherapy

Stereotactic ablative body radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumour, while limiting the dose to the surrounding tissues.

Primary Outcome Measures	Measure Description	Time Frame
The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.	Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery	Up to 30days post surgery

Secondary Outcome Measures	Measure Description	Time Frame
Measure of surgical resection margin status following pre-operative SABR and immediate surgery	Measure of Resection margin status (R0 complete resection, R1 microscopic residual tumour, R2 macroscopic residual tumour) from the post surgery histopathology report	Post surgery
Measure of local control post SABR and surgery	Number of patients with local control from CT scans up to 12months from the start of SABR	1 year
Measure of disease-free survival post SABR and surgery	Number of patients with disease progression from CT scans up to 12months from the start of SABR	1 year
Measure of overall survival post SABR and surgery	Number of deaths up to 12 months from the start of SABR treatment	1 year
Acute and late toxicity of pre-operative SABR: Number of adverse events	Number of adverse events reported up to 12 months from the start of SABR treatment	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
16 Years

Accepts Healthy Volunteers:

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

AstraZeneca

Investigators

PRINCIPAL_INVESTIGATOR: Thankamma Ajithkumar, Cambridge University Hospitals NHS Foundation Trust

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record