A Randomized, Phase II Clinical Trial of Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma
Medical College of Wisconsin
Summary
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.
Description
RATIONALE: There are limited studies comparing novel radiation treatments with stereotactic body radiation therapy (SBRT) in pancreatic adenocarcinoma to conventional fractionation. Much of the existing literature indicates this technique is safe and convenient for patients, as compared with conventionally fractionated concurrent chemo-radiation therapy. However, there has been no direct comparison of these two treatment modalities when given in the preoperative setting. It also remains uncertain if SBRT results in similar nodal downstaging to preoperative, conventionally fractionated chemo-RT…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Pathologically confirmed (histologic or cytological), resectable, borderline resectable, or locally advanced type A adenocarcinoma of the pancreas; patients must have resectable, borderline resectable, or locally advanced type A disease, based on institutional standardized criteria and tumor board review. 2. Patients with and without regional adenopathy are eligible. 3. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by multidisciplinary review. This "equivocal" definition can…
Interventions
- RadiationStereotactic Body Radiation Therapy
Undergo SBRT
- RadiationPreoperative Fractionated Radiation Therapy and Chemotherapy
Conventional concurrent chemotherapy and radiation therapy.
Location
- Froedtert Hospital & Medical College of WisconsinMilwaukee, Wisconsin