Using radiation therapy during surgery for pancreatic cancer treatment
A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma
This study is testing if giving radiation directly to the tumor area during surgery can help people with localized pancreatic cancer who have already received other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05141513 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety of intraoperative radiation therapy (IORT) in patients with localized pancreatic cancer who have undergone neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT). The approach involves delivering a concentrated dose of radiation directly to the tumor area during surgical resection to improve local cancer control. The study focuses on treating the 'Triangle Volume' around the pancreas, which is at high risk for residual cancer cells. The treatment includes a single dose of 15 Gy of radiation during surgery, targeting the area surrounding the pancreas.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with resectable pancreatic adenocarcinoma who are eligible for SBRT and surgical exploration.
Not a fit: Patients with previous abdominal radiation therapy, non-localized disease, or those unable to undergo the Whipple procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance local control of pancreatic cancer and potentially improve patient outcomes.
How similar studies have performed: Previous studies have suggested that intraoperative radiation therapy may improve outcomes in similar contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Amol Narang, MD — JHU, School of Medicine, SKCCC
- Study coordinator: Amol Narang, MD
- Email: anarang2@jh.edu
- Phone: 410-502-3828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.