Cancer of Pancreas
Conditions
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.
Interventions
RADIATIONPre-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.
Sponsors
CCTU- Cancer Theme
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days. | Up to 30days post surgery | Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of surgical resection margin status following pre-operative SABR and immediate surgery | Post 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 | 1 year | 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 | 1 year | 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 | 1 year | 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 | 1 year | Number of adverse events reported up to 12 months from the start of SABR treatment |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORThankamma Ajithkumar
Cambridge University Hospitals NHS Foundation Trust
Outcome results
None listed