New radiation approach targets tough pancreatic tumors
NCT ID NCT01972919
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether giving higher doses of radiation, guided by MRI, can help people with pancreatic cancer that cannot be removed by surgery. Participants must have already had several months of chemotherapy without the cancer spreading. The goal is to see if this approach improves survival at one and two years after treatment.
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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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23 people
The number who actually took part.
- Started
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Dec 2015
- Finished
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Jun 2026
- 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: * Pathologically confirmed (histologic or cytologic), locally advanced, adenocarcinoma of the pancreas; patients must have unresectable disease based on institutional standardized criteria of unresectability or medical inoperability. * Participants with and without regional adenopathy are eligible. * No distant metastases, based upon the following minimum diagnostic workup: * History/physical examination, including collection of weight and vital signs, within 28 days prior to study entry; * Abdominal/pelvic CT scan with IV contrast within 21 days prior to study entry; * Chest CT scan, or X-ray within 21 days prior to study entry. * Abdominal/pelvic MR prior to radiation with perfusion and diffusion- weighted sequences and MR and CT sim for radiation planning Pet scan within 21 days prior to study entry, Functional renal study. * Zubrod performance status 0-1 within 1 week of study entry. * Age ≥ 18. * Hematology and cancer antigen (CA) 19-9 / carcinoembryonic antigen (CEA) within 14 days prior to study entry, as follows. * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3; * Platelets ≥ 100,000 cells/mm\^3; * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); * Serum creatinine ≤ 1.5 mg/dl; * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 x upper limit of normal (ULN); * Total bilirubin \< 3.0 mg/dL; * Alkaline phosphatase \< 3 x ULN; * Fasting blood glucose \< 160 mg/dl. * Negative serum pregnancy test (if applicable) within 14 days prior to study entry. * Ability to swallow oral medications. * Participants must have had at least 4 months of prior systemic chemotherapy. * Participants must provide study specific informed consent prior to study entry. * Women of childbearing potential and male participants who are sexually active must practice adequate contraception. Exclusion criteria: * Distant metastatic disease, second malignancy or peritoneal seeding; * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. * Any major surgery within 28 days prior to study entry * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * Transmural myocardial infarction within 3 months prior to study entry; * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration; * Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function; * Any unresolved bowel or bile duct obstruction; * Major resection of the stomach or small bowel that could affect the absorption of capecitabine * Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women, for 3 months after the last study drug administration. * Women who are lactating at the time of registration and who plan to be lactating through 3 months after the last study drug administration. * Prior allergic reaction to capecitabine or gemcitabine * Inability to undergo an MR of the abdomen/pelvis * Participation in another clinical treatment trial while on study.
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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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Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
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