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

Not Applicable

• Conditions: Cancer of Pancreas
• Interventions: Radiation: Pre-operative stereotactic ablative body radiotherapy

• Registration Number: NCT04128332
• Lead Sponsor: CCTU- Cancer Theme

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2020-10-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-09
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic ablative radiotherapy (SABR)	Pre-operative stereotactic ablative body radiotherapy	Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom