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

NCT ID: NCT04128332

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2022-12-31

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.

Conditions

Cancer of Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Stereotactic ablative radiotherapy (SABR)

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

Group Type: OTHER

Pre-operative stereotactic ablative body radiotherapy

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

CCTU- Cancer Theme

OTHER

Sponsor Role: lead

Responsible Party

CCTU- Cancer Theme

Dr Thankamma Ajithkumar, Consultant Clinical Oncologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Thankamma Ajithkumar

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Locations

Addenbrookes Hospital

Cambridge, , United Kingdom

Countries

United Kingdom

Other Identifiers

PORTICO-SABR

Identifier Type: -

Identifier Source: org_study_id