New radiation approach aims to tame pancreatic cancer with fewer side effects
NCT ID NCT04452357
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new type of radiation called pulsed low-dose-rate (PLDR) for people with pancreatic cancer that cannot be removed right away. The radiation is given in small, spaced-out bursts along with the chemotherapy drug gemcitabine. The goal is to see if this approach causes fewer stomach and bowel side effects than standard radiation. Only 12 participants are being studied to check safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PLDR radiation and gemcitabine
- What this could lead to
- If successful, this could lead to a safer way to shrink pancreatic tumors before surgery, with fewer side effects than standard radiation.
- What could go wrong
- This is a very early, small phase I trial with only 12 participants. It primarily tests safety, not effectiveness, and may not work or benefit future patients.
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
-
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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12 people
The number who actually took part.
- Started
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Jan 2020
- 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: * Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma. * Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection. This includes the following: * Any involvement (defined as loss of fat plane on contrast CT) of any of the following vessels\*: * Common hepatic artery * Superior mesenteric artery * Celiac axis * Superior mesenteric vein * Portal vein * Aorta * These criteria will be judged by the operating surgeon in conjunction with a radiologist prior to enrollment. * Poor performance status not immediately conducive to radical surgery * Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation * Patients must have evaluable disease as measured by RECIST 1.1 criteria. * Planned surgical resection at the time of enrollment (may be initially staged as resectable, borderline resectable, or locally-advanced/unresectable). * Eastern Cooperative Oncology Group, or ECOG, performance status 0-2. * Adequate bone marrow, hepatic, renal function. * ANC ³ 1,500/ml and PLT ³ 100,000/ml * Bilirubin less than 1.5 ULN * AST and ALT \< 3X ULN * Serum Creatinine \<1.5X ULN * Prior chemotherapy allowed, but not mandatory. Patients who have undergone chemotherapy prior to participating in this study must have had a 2 week washout period at the time of signing the consent form. * Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration. Postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed. Please refer to section 6.4 for additional detail. * Age \> 18 years * 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 and follow up. Exclusion Criteria: * Radiological or cytologically confirmed metastatic disease * Patients who have had any prior therapy for pancreatic cancer, except chemotherapy (see 6.1.7) * Concurrent non-study chemotherapy or biologic therapy * A history of ataxia telangiectasia or other documented history of radiation hypersensitivity * Scleroderma or active connective tissue disease * Active inflammatory bowel disease * Serious, active infections requiring treatment with IV antibiotics * Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.
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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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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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Other studies related to the condition(s) this trial covers.
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