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

Cancer of Pancreas Clinical Trial

— PORTICO-SABR  

Official title:

Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04128332
• Other study ID #: PORTICO-SABR
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: December 2022

Study information

• Verified date: February 2021
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Pancreas
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Addenbrookes Hospital	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
CCTU- Cancer Theme	AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Measure of overall survival post SABR and surgery	Number of deaths up to 12 months from the start of SABR treatment	1 year
Secondary	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