NCT05141513Active, not recruitingPhase 1
Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma
A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 23 Nov 2021
- Start date
- 6 May 2022
- Primary completion date
- 2 Jul 2025
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Pancreatic cancer
- NCT number
- NCT05141513
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 20
- From 6 May 2022 to the primary completion date, 2 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous thoracic/abdominal radiation therapy
- Any arterial reconstruction during surgery
- Currently enrolled in another investigational drug or device trial that clinically interferes with this study
Other illness
- Evidence of disease not localized to the pancreas
Other
- Unable to receive SBRT at JHU
- Duodenal invasion detected on imaging which would exclude candidacy for SBRT
- Tumor located in pancreatic body or tail
- Unable to undergo Whipple procedure
- Unable to comply with study requirements or follow-up schedule
- 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
Who the study is looking for
- Age \> 18 years old
- Resectable/BRPC/LAPC as defined by NCCN guidelines (Figure 1) as follows confirmed via CT, EUS, or other imaging modalities.
- ECOG performance status 0-2
- 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.
- Candidate for SBRT at JHU
- Upfront treatment with multi-agent chemotherapy
- Candidate for surgical exploration at JHU
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.