Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma

NCT03704662 | Recruiting DMC FDA Device

• 1 other identifier: PRO00033061
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

resectable pancreatic adenocarcinoma; borderline resectable pancreatic adenocarcinoma; Stereotactic Body Radiation Therapy; Preoperative Fractionated Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• The number of subjects who present with node-positive disease following surgical resection.

  Subjects will undergo surgical resection within three to eight weeks following treatment.

  8 weeks postradiation

Study Arms (2)

Stereotactic Body Radiation Therapy

OTHER

Patients undergo Stereotactic Body Radiation Therapy (25 to 35 Gy over five fractions)

Radiation: Stereotactic Body Radiation Therapy

Preoperative Fractionated Radiation Therapy and Chemotherapy

OTHER

Concurrent chemotherapy with radiation treatment (50.4 Gy over 28 fractions).

Radiation: Preoperative Fractionated Radiation Therapy and Chemotherapy

Interventions

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SBRT

Stereotactic Body Radiation Therapy

Preoperative Fractionated Radiation Therapy and Chemotherapy RADIATION

Conventional concurrent chemotherapy and radiation therapy.

Preoperative Fractionated Radiation Therapy and Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Distant metastatic disease.
• Prior invasive malignancy (except nonmelanomatous skin cancer), unless disease free for a minimum of three years (for example, carcinoma in situ of the breast, oral cavity or cervix are all permissible).
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Any major surgery within 28 days prior to study entry (for example, insertion of a vascular access device or biliary stent, exploratory laparotomy and/or laparoscopy are not considered major surgery; biliary or gastric bypass is considered major surgery).
• Severe, active comorbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
• Transmural myocardial infarction within three months prior to study entry.
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
• Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function.
• Any unresolved bowel or bile duct obstruction.
• Major resection of the stomach or small bowel that could affect the absorption of capecitabine.
• Acquired immune deficiency syndrome (AIDS), based upon current Center for Disease Control (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with capecitabine.
• Absence of any significant medical comorbidity which would preclude the consideration of major pancreatic surgery.
• Women who are lactating at the time of registration and who plan to be lactating through three months after study therapy is completed.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William Hall, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

414-805-8900; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 15, 2018
• Study Start: October 22, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2031
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)