Surgical radiation zaps pancreatic tumors from inside
NCT ID NCT03716531
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study tests whether giving a precise dose of radiation directly to the tumor during surgery (intraoperative radiation therapy, or IORT) can help people with pancreatic cancer that has grown into nearby blood vessels. Participants first receive standard chemotherapy and radiation, then undergo surgery with the IORT boost. The main goal is to see if this approach improves 2-year survival rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- electron beam intraoperative radiation therapy (IORT)
- What this could lead to
- If successful, this approach could improve survival and local control for patients with pancreatic cancer that involves nearby blood vessels.
- What could go wrong
- This is a single-arm phase II study without a control group, so benefits are uncertain. The treatment is intensive and may not improve outcomes over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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199 people
The number who actually took part.
- Started
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Mar 2019
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224, United States
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Mayo Clinic, Rochester
Rochester, Minnesota, 55905, United States
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Ohio State University Medical Center
Columbus, Ohio, 43210, United States
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University of California, Irvine
Irvine, California, 92697, United States
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University of North, Carolina Chapel Hill
Chapel Hill, North Carolina, 27514, United States
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