Status:
UNKNOWN
Neoadjuvant Stereotactic Ablative Radiotherapy for Pancreatic Ductal Adenocarcinoma
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
London Health Sciences Foundation
Conditions:
Resectable Pancreatic Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pancreatic cancer (PC) is expected to be the third leading cause of cancer death in Canada in 2019 \[1\]. Localized pancreatic cancer may be classified as resectable, borderline resectable, or locally...
Detailed Description
Goals: The primary goals of this study are to evaluate the safety and feasibility of neoadjuvant SABR patients with surgical PC. This proposal is specifically intended to strengthen the correlative sc...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Both Arms):
- Age 18 or older
- Able to provide informed consent
- Histologically confirmed primary pancreatic cancer, or willing to undergo endoscopic ultrasound (EUS) with synchronous fiducial marker placement and biopsy
- No evidence of distant metastases (M0)
- Medically fit to undergo surgical resection
- Life expectancy \>6 months
- Adequate renal function to tolerate contrast dye for imaging
- ECOG Performance Status 0-2 Inclusion Criteria (Arm 1)
- Upfront resectable pancreatic cancer
- No evidence of nodal disease (N0)
- Appropriate to undergo a pancreaticoduodenectomy within 4-6 weeks of registration
- Inclusion Criteria (Arm 2)
- Borderline resectable or upfront resectable pancreatic cancer
- Plan for surgical resection independent of the biochemical or radiographic response to SABR
- Exclusion Criteria (Both Arms):
- Serious medical comorbidities or other contraindications to radiotherapy or surgery
- Gross disease involving duodenum or stomach
- Unable to have fiducials placed.
- Recurrent pancreatic cancer
- Prior abdominal radiation at any time
- Inability to attend full course of radiotherapy, surgery, or follow-up visits
- Contrast allergy
- Pregnant or lactating women
- Exclusion Criteria (Arm 1):
- Receipt of any neoadjuvant system therapy, standard cytotoxic therapy or experimental
- Exclusion Criteria (Arm 2):
- Elevated bilirubin or liver enzymes considered to be a contraindication to irinotecan chemotherapy, unless an intervention is planned to improve hepatic functioning
Exclusion
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04915417
Start Date
August 1 2021
End Date
August 1 2024
Last Update
June 22 2021
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