New adaptive radiation aims to spare the gut in pancreatic cancer
NCT ID NCT05764720
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This trial is testing a new type of radiation therapy that adapts daily to the exact shape and position of a pancreatic tumor. The goal is to deliver a high, tumor-killing dose while minimizing damage to nearby stomach and intestines. About 134 people with borderline resectable or locally advanced pancreatic cancer who have already had chemotherapy will take part. The main focus is on whether this approach lowers severe gastrointestinal side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Daily adaptive external beam radiation therapy
- What this could lead to
- If successful, this approach could offer a safer way to deliver high-dose radiation to pancreatic tumors, reducing severe gastrointestinal side effects while maintaining tumor control.
- What could go wrong
- This is a single-arm, non-randomized trial, so results may not be definitive. The technique is complex and may not be widely available. Side effects, though reduced, can still occur.
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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About 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: 1. Histologically or cytologically confirmed borderline-resectable (based on NCCN criteria), locally-advanced (based on NCCN criteria), or medically inoperable pancreatic adenocarcinoma. 2. ECOG performance status 0-1 3. Receipt of at least two months of lead-in chemotherapy (regimen at the discretion of the treating physician) prior to planned initiation of CT-STAR. 4. Limited regional lymphadenopathy permitted. Node positive patients are restricted to those with up to 3 clinically involved (greater than 1cm on cross-sectional imaging or pathologically proven) nodes provided that the lymph nodes are adjacent to the primary tumor. 5. At least 18 years of age. 6. Must be able to take an interruption in systemic therapy at least one week prior to planned start of CT-STAR (two weeks preferred) lasting for the duration of CT-STAR and continuing for at least one week following end of CT-STAR (two weeks preferred). 7. Capable of a single end-exhale breath-hold of at least 20 seconds in duration and of repeated end-exhale or deep inspiratory breath-hold of at least 10 seconds in duration upon verbal instruction. 8. Anatomy of target and adjacent OARs adequately visualized on ETHOS simulation imaging, as determined by treating and study physicians. Note: central review of simulation imaging and initial plan target/OAR contours by the Principal Investigator and Physics lead is required for the first two patients at each participating institution prior to study treatment delivery. Patients with inadequate anatomic visualization at simulation will be considered screen-failures and treated off-protocol as per institutional standard-of-care. 9. Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: 1. Past history of radiotherapy within the projected treatment field 2. Prior, intercurrent, or planned receipt (within 90 days prior to or following SBRT) of any investigational agents related to pancreatic cancer diagnosis. 3. Competing, active cancer diagnosis within the preceding one year. 4. 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. 5. Gross tumor invasion of the stomach or duodenum (defined either radiographically or endoscopically). 6. Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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City of Hope
RECRUITINGDuarte, California, 91010, United States
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UH Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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University of Alabama at Birmingham
RECRUITINGBirmingham, Alabama, 35205, United States
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Washington University, St. Louis
RECRUITINGSt Louis, Missouri, 63130, United States
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Other studies related to the condition(s) this trial covers.
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- Can a blood test before pancreatic surgery predict a dangerous leak?
- New chemo cocktail targets pancreatic cancer at every stage
- Bacteria-Based immunotherapy targets pancreatic tumors in first human test