Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04128332
Other study ID # PORTICO-SABR
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 26, 2020
Est. completion date December 2022

Study information

Verified date February 2021
Source Cambridge University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Pre-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.

Locations

Country Name City State
United Kingdom Addenbrookes Hospital Cambridge

Sponsors (2)

Lead Sponsor Collaborator
CCTU- Cancer Theme AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Terminated NCT02902484 - Study of Nintedanib and Chemotherapy for Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT04008537 - Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device N/A
Recruiting NCT04809935 - EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy Phase 4
Not yet recruiting NCT03659292 - Effects of Epidural Block on the Prognosis in Patients With Pancreatic Cancer Undergoing Distal Pancreatectomy N/A
Completed NCT03150615 - Enteral Nutrition After Pancreaticoduodenectomy N/A
Recruiting NCT02682394 - Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas N/A
Recruiting NCT05566743 - A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas Phase 2
Not yet recruiting NCT04049461 - Heterotopic Ossification in Abdominal Incision and Pancreatic Cancer
Recruiting NCT04164602 - The Occurence of Pancreatic Cancer Studied in Association With Newly Diagnosed Diabetes in the Elderly
Recruiting NCT03536793 - Tumour Regulatory Molecules in Early Pancreatic Cancer Detection
Recruiting NCT02311439 - Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas Phase 2/Phase 3
Completed NCT02296736 - The Pre-operative Pathway in Pancreatic Head Malignancy-assessment of the Diagnostic Accuracy of Staging CT Scan
Withdrawn NCT04123574 - A Pilot Study of BXCL701 in Patients With Pancreatic Cancer Early Phase 1
Not yet recruiting NCT03278015 - Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients Phase 2
Active, not recruiting NCT02905578 - A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1) Phase 2
Completed NCT01446458 - Phase I Study of Stereotactic Body Radiation Therapy and FOLFIRINOX in the Neoadjuvant Therapy of Pancreatic Cancer Phase 1
Recruiting NCT04677244 - Echo-endoscopy Biopsy Impact on the Circulating Tumor Cell Level N/A
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Recruiting NCT06148298 - Cell-Free DNA Chromatin Immunoprecipitation (ChIP) for Diagnosing Cancer
Terminated NCT03451773 - M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas Phase 1/Phase 2