Clinical trial NCT04128332: Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery for Pancreatic Cancer
Official title: Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Pancreas
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-10-16
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days.
timeFrame: Up to 30days post surgery
Secondary outcomes:
measure: Measure of surgical resection margin status following pre-operative SABR and immediate surgery
timeFrame: Post surgery
measure: Measure of local control post SABR and surgery
timeFrame: 1 year
measure: Measure of disease-free survival post SABR and surgery
timeFrame: 1 year
measure: Measure of overall survival post SABR and surgery
timeFrame: 1 year
measure: Acute and late toxicity of pre-operative SABR: Number of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Thankamma Ajithkumar
role: PRINCIPAL_INVESTIGATOR
References: