NCT05141513 Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma
| NCT ID | NCT05141513 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2022-05-06 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2022-05-06 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
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 potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
Contact & Investigator
Amol Narang, MD
PRINCIPAL INVESTIGATOR
JHU, School of Medicine, SKCCC
Frequently Asked Questions
Who can join the NCT05141513 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05141513 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05141513 currently recruiting?
Yes, NCT05141513 is actively recruiting participants. Contact the research team at anarang2@jh.edu for enrollment information.
Where is the NCT05141513 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05141513 clinical trial?
NCT05141513 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Amol Narang, MD at JHU, School of Medicine, SKCCC. The trial plans to enroll 25 participants.
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