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

NCT04128332

CompletedNA

Sponsor: CCTU- Cancer Theme

Conditions: Cancer of Pancreas

Interventions: Pre-operative stereotactic ablative body radiotherapy

Countries: United Kingdom

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

Eligibility overview

Sex: ALL

Age: 16 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (1)
  • Cambridge, United Kingdom