Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma
NCT05141513 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2025-07-18
Summary
This study is designed to investigate the safety of intraoperative radiation therapy (IORT) in patients with localized pancreatic cancer undergoing surgical resection after neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT).
Conditions
Interventions
- RADIATION
-
High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)
After the patient receives standard of care treatment, they will receive a single dose of radiation (15 Gy) at the time the tumor is surgically removed. Surgeons will then place clips along the blood vessels around the surgical area. These clips will be used to confirm (after surgery) that the expected dose of radiation was received during surgery.
Sponsors & Collaborators
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Amol Narang, MD · JHU, School of Medicine, SKCCC
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-06
- Primary Completion
- 2026-07-31
- Completion
- 2028-04-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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