NCT03716531

Brief Summary

This research study is studying an intervention as a possible treatment for pancreatic cancer.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Mar 2019Dec 2027

First Submitted

Initial submission to the registry

October 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 19, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

6.4 years

First QC Date

October 21, 2018

Last Update Submit

December 2, 2025

Conditions

Pancreas Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 2 Year Overall Survival

    Overall survival is defined as the time from IORT to death due to any cause, or is censored at the date of last follow-up, when applicable.

    2 years

Secondary Outcomes (3)

  • Median Progression Free Survival

    2 years

  • Local Control

    2 years

  • Adverse events associated with IORT

    2 years

Study Arms (1)

IORT

EXPERIMENTAL

* IORT will be administered as determined to be best practice by the treating radiation oncologist, * Electron beam intraoperative radiation therapy will occur in a hybrid operating room with a portable linear accelerator

Radiation: IORT

Interventions

IORTRADIATION

IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy

IORT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • ECOG Performance Status 0-1
  • Previous completion of at least three (3) months of EITHER gemcitabine plus nab-paclitaxel OR FOLFIRINOX (5-fluorouracil, oxaliplatin, irinotecan and leucovorin)
  • Previous completion of either stereotactic-body radiation therapy (SBRT) (minimum 24 Gy) or external beam irradiation (EBRT) (minimum 45 Gy)
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment is PERMITTED.
  • Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 5 months after IORT.
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after IORT. Women who are not of childbearing potential, i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Evidence of disease progression or distant metastases.
  • Pregnant or lactating women
  • Treatment for other invasive carcinomas within the last five years who are at greater than 5% risk of recurrence at time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowed.
  • Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • An active infection requiring systemic therapy
  • Other serious medical conditions that the investigator feels might compromise study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of California, Irvine

Irvine, California, 92697, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

University of North, Carolina Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Jennifer Wo, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2018

First Posted

October 23, 2018

Study Start

March 19, 2019

Primary Completion

August 26, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(6)