Personalized radiation aims to outsmart tough pancreatic tumors
NCT ID NCT06984562
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adaptive radiation therapy (ART) can safely deliver higher, more focused radiation doses to pancreatic tumors while protecting nearby organs. Sixteen adults with locally advanced, inoperable pancreatic cancer will receive five treatments over two weeks. The main goal is to check for serious side effects, with secondary goals of seeing if the tumor stays controlled and how long patients live.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adaptive Radiation Therapy (ART)
- What this could lead to
- If successful, this approach could make radiation therapy safer and more effective for people with inoperable pancreatic cancer, potentially improving local tumor control and quality of life.
- What could go wrong
- This is a very early, small Phase I trial with only 16 participants. It primarily tests safety and dosing, not effectiveness. The cancer is advanced and hard to treat, so benefits may be limited.
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 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2029
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 1. Patients must have histologically or cytologically-confirmed PDA. 2. Patients must have locally advanced unresectable PDA. • This includes the following- per NCCN criteria\*: 2.1 Unreconstructible involvement with the superior mesenteric vein or portal vein due to tumor or bland thrombus OR 2.2 Solid tumor contact with greater than 180 degrees of the superior mesenteric artery or celiac artery OR 2.3. Solid tumor contact with the aorta OR 2.4. Patients with non-metastatic disease that is inoperable by virtue of the operation posing excessive risk to the patient \*All patients must have been reviewed in the multidisciplinary conference and determined to have unresectable disease by a pancreatic surgeon and to have received or be ineligible for induction chemotherapy based on medical oncology assessment. Documentation of this review in EPIC meeting minutes will satisfy this requirement. 3. Patients enrolled onto the dose escalation arm may have started chemotherapy prior to initiation of radiation therapy and the last dose of chemotherapy must occur at least 2 weeks before start of ART. 4. Eastern Cooperative Oncology Group, or ECOG, performance status 0-2. 5. Adequate bone marrow, hepatic, renal function: * ANC ≥ 1,500/µl and PLT ≥ 100,000/µl * Bilirubin less than 1.5 ULN * AST and ALT \< 3X ULN * Serum Creatinine \<1.5X ULN 6. Women of childbearing potential must not be pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrheal and non-lactating for at least 12 months to be considered of non-childbearing potential. Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for at least 6 months after therapy is completed. 7. Age ≥ 18 years 8. Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment, tissue sample collections, and follow-up. Exclusion Criteria 1. Radiologically or cytologically confirmed metastatic disease. 2. Patients who have had any prior radiation therapy for pancreatic cancer. 3. Patients who have had prior chemoradiation to an overlapping volume. 4. Patients with adenosquamous carcinoma of the pancreas. 5. Subjects who have had chemotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier to \< Grade 2. Patients who received previous immunotherapy or other antibody therapy, within 28 days (immune related toxicities must have resolved to \<= Grade 2 prior to starting treatment). Study treatment may be started within these washout periods or with continuing toxicities if considered by the Sponsor-Investigator to be safe and within the best interest of the patient. 6. Concurrent non-study chemotherapy or biologic therapy. 7. A history of ataxia telangiectasia or other documented history of radiation hypersensitivity. • Includes both bi- and mono-allelic likely pathogenic or pathogenic ATM mutations (VUS is acceptable). 8. Serious, active infections requiring treatment with IV antibiotics
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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
1 site. 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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Fox Chase Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19111, United States