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
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.
• 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.
• Patients with and without regional adenopathy are eligible.
• 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 include small lung or liver lesions that are not able to be radiographically characterized otherwise. Any biopsy-proven metastatic disease will make the patient ineligible for study participation.
• History/physical examination, including collection of weight and vital signs, within 45 days prior to start of treatment.
• Diagnostic abdominal/pelvic CT with IV contrast or abdominopelvic MRI scan with perfusion and diffusion-weighted sequences within 45 days prior to study entry.
• Chest CT scan or X-ray within 30 days prior to study entry.
• Radiation treatment planning abdominal CT. A recommended abdominal MRI will be done as a simulation (SIM) with interpretation. The CT SIM will not be done with interpretation. Positron emission tomography (PET) scan and MRI are both optional but encouraged. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is optional but encouraged.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 14 days of randomization.
• Age ≥ 18.
⁃ Heme Onc (Chem 24) and cancer antigen (CA) 19-9/carcinoembryonic antigen (CEA) within 45 days prior to treatment, as follows:
∙ Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
‣ Platelets ≥100,000 cells/mm3 (see section 4)
‣ Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
‣ Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal
‣ Total bilirubin \< 1.5 x upper normal mg/dL
‣ Alkaline phosphatase \< 4 x upper limit of normal
⁃ Not on hemodialysis.
⁃ Negative serum pregnancy test (if applicable).
⁃ Ability to swallow oral medications.
⁃ Patients must have had at least one cycle of systemic chemotherapy without evidence of distant progression.
⁃ Patient must provide study-specific informed consent prior to study entry.
⁃ Women of childbearing potential and male participants who are sexually active must practice adequate contraception.