Pancreatic cancer radiation combo trial cut short
NCT ID NCT04975516
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether adding a precise type of radiation (stereotactic body radiation therapy) to standard chemotherapy could better control pancreatic cancer that has spread to only a few spots in the body. The trial planned to enroll patients with limited metastases, but it was stopped early after only 3 participants. The goal was to see if the combination could delay cancer growth and improve survival, but results are limited due to early termination.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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2 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Nov 2025
- 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 * Histologically confirmed adenocarcinoma of pancreatic origin with pathologic material reviewed by the Department of Pathology at Mayo Clinic, if available and applicable * Image proven oligometastatic pancreatic cancer patients (i.e., synchronous \& metachronous) * Oligometastatic defined as: =\< 5 extracranial metastatic tumors (brain metastasis patients are excluded; indeterminate lung nodules stable on 2 consecutive imaging studies spaced more than 4 weeks apart will not count as sites of oligometastatic disease) * All sites must be amenable to SBRT (positive peritoneal washings cytology or Kras cell free (cf)DNA, and positive peritoneal biopsy would be considered ineligible) * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Non-measurable disease * NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Negative pregnancy test done =\< 7days prior to registration, for women of childbearing potential only * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Ability to complete questionnaire(s) by themselves or with assistance * Provide written informed consent * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) * Willing to provide tissue and/or blood samples for correlative research purposes * Hemoglobin \>= 9.0 g/dL (obtained =\< 28 days prior to registration) * Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 28 days prior to registration) * Platelet count \>= 100,000/mm\^3 (obtained =\< 28 days prior to registration) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (If known Gilbert's syndrome, then =\< 3.0 x ULN) (obtained =\< 28 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 3 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 28 days prior to registration) * Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =\< 28 days prior to registration) * Calculated creatinine clearance \>= 45 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to registration) Exclusion Criteria: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception * Any of the following prior therapies: * Surgery =\< 3 weeks prior to registration * Prior radiation to an overlapping area * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * 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 * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Other active malignancy =\< 1 year prior to registration * EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer * History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
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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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Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
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Other studies related to the condition(s) this trial covers.
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