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

NCT05141513 | Recruiting Phase 1 DMC FDA Device

• 2 other identifiers: J21105IRB00294801
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Acute post-operative toxicity of targeted IORT

  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.

  3 months

Secondary Outcomes (16)

• Late post-operative toxicity of targeted IORT

  6 months

• Late post-operative toxicity of targeted IORT

  12 months

• Late post-operative toxicity of targeted IORT

  24 months

• Late post-operative toxicity of targeted IORT

  36 months

• Median local-progression free survival (LPFS) from IORT

  6 months

Study Arms (1)

Intra Operative Radiation Therapy (IORT) Group

OTHER

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.

Radiation: High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)

Interventions

High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT) RADIATION

After the patient receives standard of care treatment, they will receive a single dose of radiation (15 Gy) at the time the tumor is surgically removed. Surgeons will then place clips along the blood vessels around the surgical area. These clips will be used to confirm (after surgery) that the expected dose of radiation was received during surgery.

Intra Operative Radiation Therapy (IORT) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous thoracic/abdominal radiation therapy
• 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
• Evidence of disease not localized to the pancreas
• Any arterial reconstruction during surgery
• Currently enrolled in another investigational drug or device trial that clinically interferes with this study
• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (1)

• Reddy 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 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Amol Narang, MD

  JHU, School of Medicine, SKCCC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amol Narang, MD

CONTACT

410-502-3828; anarang2@jh.edu

Dana B Kaplin, MPH

CONTACT

410-502-3950; dkaplin1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single institution, single arm pilot study to evaluate the safety and feasibility of implementing IORT in patients with non-metastatic Pancreatic adenocarcinoma (PDAC) who have been treated with neoadjuvant chemotherapy and SBRT and who are undergoing surgical resection.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 2, 2021
• Study Start: May 6, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)