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

Primary Purpose

Cancer of Pancreas

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pre-operative stereotactic ablative body radiotherapy
Sponsored by
CCTU- Cancer Theme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer of Pancreas

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addenbrookes Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Stereotactic ablative radiotherapy (SABR)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Measure of overall survival post SABR and surgery
Number of deaths up to 12 months from the start of SABR treatment
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

Full Information

First Posted
October 8, 2019
Last Updated
February 5, 2021
Sponsor
CCTU- Cancer Theme
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04128332
Brief Title
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer
Acronym
PORTICO-SABR
Official Title
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CCTU- Cancer Theme
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic ablative radiotherapy (SABR)
Arm Type
Other
Arm Description
Stereotactic ablative radiotherapy (SABR) delivering 35Gy in five fractions (7Gy/fraction) over 5 days.
Intervention Type
Radiation
Intervention Name(s)
Pre-operative stereotactic ablative body radiotherapy
Intervention Description
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 Measure Information:
Title
The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.
Description
Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery
Time Frame
Up to 30days post surgery
Secondary Outcome Measure Information:
Title
Measure of surgical resection margin status following pre-operative SABR and immediate surgery
Description
Measure of Resection margin status (R0 complete resection, R1 microscopic residual tumour, R2 macroscopic residual tumour) from the post surgery histopathology report
Time Frame
Post surgery
Title
Measure of local control post SABR and surgery
Description
Number of patients with local control from CT scans up to 12months from the start of SABR
Time Frame
1 year
Title
Measure of disease-free survival post SABR and surgery
Description
Number of patients with disease progression from CT scans up to 12months from the start of SABR
Time Frame
1 year
Title
Measure of overall survival post SABR and surgery
Description
Number of deaths up to 12 months from the start of SABR treatment
Time Frame
1 year
Title
Acute and late toxicity of pre-operative SABR: Number of adverse events
Description
Number of adverse events reported up to 12 months from the start of SABR treatment
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thankamma Ajithkumar
Organizational Affiliation
Cambridge University Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
Cb2 0QQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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