Actively Recruiting
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
Led by Medical College of Wisconsin · Updated on 2025-10-08
102
Participants Needed
1
Research Sites
657 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients are randomized into two arms. Arm A patients will receive Stereotactic Body Radiation Therapy (SBRT) and Arm B patients with receive conventional concurrent chemotherapy and radiation therapy.
CONDITIONS
Official Title
Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed resectable, borderline resectable, or locally advanced type A pancreatic adenocarcinoma
- Patients with or without regional adenopathy
- No biopsy-proven distant metastatic disease; patients with radiologically equivocal distant lesions may be included
- History and physical exam including weight and vital signs within 45 days before treatment start
- Diagnostic abdominal/pelvic CT with IV contrast or MRI within 45 days before enrollment
- Chest CT scan or X-ray within 30 days before enrollment
- Radiation treatment planning abdominal CT and recommended abdominal MRI simulation
- ECOG performance status of 0-2 within 14 days before randomization
- Age 18 years or older
- Blood counts and liver function tests within specified levels within 45 days before treatment
- Not on hemodialysis
- Negative pregnancy test if applicable
- Ability to swallow oral medications
- At least one cycle of systemic chemotherapy completed without disease progression
- Signed informed consent
- Use of adequate contraception for women of childbearing potential and sexually active men
You will not qualify if you...
- Distant metastatic disease confirmed by biopsy
- Prior invasive malignancy unless disease free for at least three years
- Prior radiotherapy overlapping the study cancer region
- Major surgery within 28 days before enrollment
- Severe active comorbidities including unstable angina, recent myocardial infarction, infections needing IV antibiotics, respiratory illnesses requiring hospitalization, malabsorption syndromes, unresolved bowel or bile duct obstruction, major stomach or small bowel resection affecting drug absorption, or AIDS
- Pregnancy or unwillingness to use contraception during and after the study
- Lactating women planning to continue lactation through three months after treatment
- Prior allergic reaction to capecitabine or gemcitabine
- Participation in another interventional treatment trial during the study
- Use of nonprotocol chemotherapy or immune-modulating agents for other conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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