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

NCT ID: NCT05141513

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2028-04-30

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).

Detailed Description

Standard of care treatment for patients with non-metastatic pancreatic adenocarcinoma (PDAC) includes chemotherapy and Stereotactic Body Radiation Treatment (SBRT) followed by surgical resection of the tumor with or without Intra-Operative Radiation Therapy (IORT).

There is some evidence from other research studies suggesting that adding radiation treatment during the surgical resection may improve local control of the cancer. The use of IORT plus surgical resection can be used to treat pancreatic cancer and is done on a case by case basis at Johns Hopkins.

The department of Radiation Oncology has developed a program using a High Dose Rate-IORT (HDR-IORT). The HDR-IORT makes it possible to deliver concentrated radiation dose at the surface of the tumor.

Our team has shown in previous studies that the majority of cancer cells that remain after treatment are located around the area of the pancreas called the "Triangle Volume" (TV). This region contains blood vessels, lymphatic vessels, and nerves, and is at high risk of containing cancer cells. This region is difficult to treat with SBRT alone because of being close to normal, healthy organs. Therefore, this study involves using IORT to treat the TV to a therapeutic radiation dose.

The part of the treatment that is considered research is:

• Giving one dose of 15 Gy during the surgery using IORT to deliver radiation, and
• Targeting the larger area around the pancreas called the TV

The goal of this study is to determine safety of this added treatment which will be assessed at 3 months after the surgery is completed.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra Operative Radiation Therapy (IORT) Group

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amol Narang, MD

Role: PRINCIPAL_INVESTIGATOR

JHU, School of Medicine, SKCCC

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amol Narang, MD

Role: CONTACT

anarang2@jh.edu

410-502-3828

Dana B Kaplin, MPH

Role: CONTACT

dkaplin1@jhmi.edu

410-502-3950

Facility Contacts

Amol Narang, MD

Role: primary

anarang2@jhmi.edu

410-502-3828

References

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.

Reference Type: DERIVED

PMID: 36307845 (View on PubMed)

Other Identifiers

IRB00294801

Identifier Type: OTHER

Identifier Source: secondary_id

J21105

Identifier Type: -

Identifier Source: org_study_id