Clinical trial · Interventional
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
NCT05141513CI-TRIAL-00120353active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Intra Operative Radiation Therapy (IORT) Group
- description
- The IORT group is the single arm of this study. Enrolled patients who undergo standard of care treatment will also receive a study treatment of High Dose Rate (HDR) Intra Operative Radiation Therapy.
- interventionNames
- Radiation: High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)
Primary outcomes (1)
- measure
- Acute post-operative toxicity of targeted IORT
- timeFrame
- 3 months
- description
- To evaluate acute post-operative toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.
Secondary outcomes (16)
- measure
- Late post-operative toxicity of targeted IORT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDReddy AV, Hill CS, Zheng L, He J, Narang AK. A safety study of intraoperative radiation therapy following stereotactic body radiation therapy and multi-agent chemotherapy in the treatment of localized pancreatic adenocarcinoma: study protocol of a phase I trial. Radiat Oncol. 2022 Oct 28;17(1):173. doi: 10.1186/s13014-022-02145-9. PMID 36307845