Status:
UNKNOWN
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer
Lead Sponsor:
CCTU- Cancer Theme
Collaborating Sponsors:
AstraZeneca
Conditions:
Cancer of Pancreas
Eligibility:
All Genders
16+ years
Phase:
NA
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-o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04128332
Start Date
October 26 2020
End Date
December 1 2022
Last Update
February 9 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Addenbrookes Hospital
Cambridge, United Kingdom, Cb2 0QQ