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Pancreatic CancerPhase 1NCT05141513

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

A Phase 1 study testing High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT) in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
6 May 2022to Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: A Safety Study of Intraoperative Radiation Therapy Following Stereotactic Body Radiation Therapy and Multi-agent Chemotherapy in the Treatment of Localized Pancreatic Adenocarcinoma

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).

Read the 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.

Being tested
High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05141513
Study groupRoleWhat they receive
Intra Operative Radiation Therapy (IORT) GroupOtherThe 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.
Receives: Radiation: High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (16)

  1. Late post-operative toxicity of targeted IORT

    To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    Measured: 6 months

  2. Late post-operative toxicity of targeted IORT

    To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    Measured: 12 months

  3. Late post-operative toxicity of targeted IORT

    To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    Measured: 24 months

  4. Late post-operative toxicity of targeted IORT

    To evaluate late toxicity of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    To evaluate late toxicity (>90 days) of IORT targeted to the TV in patients with non-metastatic PDAC undergoing surgical resection after neoadjuvant multi-agent chemotherapy and SBRT.

    Measured: 36 months

  5. Median local-progression free survival (LPFS) from IORT

    To determine the median local-progression free survival (LPFS) from time of IORT.

    Measured: 6 months

  6. Median local-progression free survival (LPFS) from IORT

    To determine the median local-progression free survival (LPFS) from time of IORT.

    Measured: 12 months

  7. Median local-progression free survival (LPFS) from IORT

    To determine the median local-progression free survival (LPFS) from time of IORT.

    Measured: 24 months

  8. Median local-progression free survival (LPFS) from IORT

    To determine the median local-progression free survival (LPFS) from time of IORT.

    Measured: 36 months

  9. Median overall survival (OS) from IORT

    To determine the median overall survival (OS) from time of IORT.

    Measured: 6 months

  10. Median overall survival (OS) from IORT

    To determine the median overall survival (OS) from time of IORT.

    Measured: 12 months

  11. Median overall survival (OS) from IORT

    To determine the median overall survival (OS) from time of IORT.

    Measured: 24 months

  12. Median overall survival (OS) from IORT

    To determine the median overall survival (OS) from time of IORT.

    Measured: 36 months

  13. Median progression free survival (PFS) from IORT

    To determine the median progression free survival (PFS) from time of IORT

    Measured: 6 months

  14. Median progression free survival (PFS) from IORT

    To determine the median progression free survival (PFS) from time of IORT

    Measured: 12 months

  15. Median progression free survival (PFS) from IORT

    To determine the median progression free survival (PFS) from time of IORT

    Measured: 24 months

  16. Median progression free survival (PFS) from IORT

    To determine the median progression free survival (PFS) from time of IORT

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start6 May 2022
  3. Primary completion2 Jul 2025
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141513
Sponsor's protocol ID
J21105
Other IDs
IRB00294801
Status last verified
Sep 2026
First submitted
23 Nov 2021
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36307845

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing High Dose Rate Brachytherapy (HDR) Intraoperative Radiation Therapy (IORT) in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute post-operative toxicity of targeted IORT (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05141513, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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