Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study ID
- NCT05141513
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT) — RADIATIONAfter 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.
Study Details
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).
Key Dates
- Start date
- May 6, 2022
- Status verified
- Jul 2025
- Primary completion
- Jul 31, 2026
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Intra Operative Radiation Therapy (IORT) GroupThe IORT group is the single arm of this study. Enrolled patients who undergo standard of care treatment will also receive a study treatment of High Dose Rate (HDR) Intra Operative Radiation Therapy.
Primary Outcome Measure
Acute post-operative toxicity of targeted IORT [ Time Frame: 3 months ]
Central Contacts
- Amol Narang, MD410-502-3828
- Dana B Kaplin, MPH410-502-3950
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 |
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