A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma

Trial ID: NCT05141513

Interventional - Phase 1 - Active, not recruiting

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

• Pancreatic Cancer

Interventions

• High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)

Eligibility

Inclusion criteria

• 1. Age \> 18 years old
• 2. Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.
• 3. ECOG performance status 0-2
• 4. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
• 5. Candidate for SBRT at JHU
• 6. Upfront treatment with multi-agent chemotherapy
• 7. Candidate for surgical exploration at JHU

Exclusion criteria

• 1. Previous thoracic/abdominal radiation therapy
• 2. Unable to receive SBRT at JHU
• 3. Duodenal invasion detected on imaging which would exclude candidacy for SBRT
• 4. Tumor located in pancreatic body or tail
• 5. Unable to undergo Whipple procedure
• 6. Evidence of disease not localized to the pancreas
• 7. Any arterial reconstruction during surgery
• 8. Currently enrolled in another investigational drug or device trial that clinically interferes with this study
• 9. Unable to comply with study requirements or follow-up schedule
• 10. Women of child bearing potential or sexually active fertile men with partners who are women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Source: ClinicalTrials.gov

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