Cancer of Pancreas Clinical Trial
— PORTICO-SABROfficial title:
Pre-operative Stereotactic Ablative Body Radiotherapy Followed by Immediate Surgery in Pancreatic Adenocarcinoma: A Window of Opportunity Feasibility Study
Verified date | February 2021 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A window of opportunity feasibility study assessing pre-operative stereotactic ablative body radiotherapy followed by immediate surgery in pancreatic adenocarcinoma.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | December 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrookes Hospital | Cambridge |
Lead Sponsor | Collaborator |
---|---|
CCTU- Cancer Theme | AstraZeneca |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The feasibility of delivering pre-operative SABR followed by immediate surgery as determined by rate of post-operative complications at 30 days. | Rate of post-operative complications measured as the number of adverse events reported up to 30 days post surgery | Up to 30days post surgery | |
Secondary | Measure of surgical resection margin status following pre-operative SABR and immediate surgery | Measure of Resection margin status (R0 complete resection, R1 microscopic residual tumour, R2 macroscopic residual tumour) from the post surgery histopathology report | Post surgery | |
Secondary | Measure of local control post SABR and surgery | Number of patients with local control from CT scans up to 12months from the start of SABR | 1 year | |
Secondary | Measure of disease-free survival post SABR and surgery | Number of patients with disease progression from CT scans up to 12months from the start of SABR | 1 year | |
Secondary | Measure of overall survival post SABR and surgery | Number of deaths up to 12 months from the start of SABR treatment | 1 year | |
Secondary | Acute and late toxicity of pre-operative SABR: Number of adverse events | Number of adverse events reported up to 12 months from the start of SABR treatment | 1 year |
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