Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Nov 23, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the safety of a treatment called intraoperative radiation therapy (IORT) for patients with localized pancreatic cancer. Patients in this study have already received chemotherapy and a type of radiation called stereotactic body radiation therapy (SBRT) before their surgery. The goal is to see if adding IORT during the surgery can help improve outcomes for these patients.

To be eligible for this trial, participants must be at least 18 years old and have a specific type of pancreatic cancer that can be surgically removed. They should also be in fairly good health, as indicated by their performance status, and must be able to give informed consent. Participants will undergo surgery at Johns Hopkins University (JHU) and will be closely monitored throughout the study. It’s important to note that there are certain criteria that might exclude someone from participating, such as having had previous radiation therapy or if the cancer has spread beyond the pancreas. Overall, this trial aims to find new ways to treat pancreatic cancer and improve patient care.

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Eligibility criteria

• 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 potenital who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study