New combo attack shows promise against tough pancreatic tumors
NCT ID NCT03991962
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a two-step treatment for people with pancreatic cancer that hasn't spread but can't be removed by surgery. First, patients receive a stronger chemotherapy cocktail (modified FOLFIRINOX), followed by precise, high-dose radiation (SBRT). The goal is to see if this approach delays cancer growth better than older treatments. The trial enrolled 28 adults with borderline or locally advanced pancreatic cancer.
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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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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Feb 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed pancreatic adenocarcinoma * Borderline resectable pancreatic adenocarcinoma or locally advanced pancreatic adenocarcinoma * No evidence of extrapancreatic disease on diagnostic imaging * No evidence of invasion into the duodenum or stomach, as determined by EGD/EUS * No prior treatment (chemotherapy, biological therapy, or radiotherapy) for pancreatic cancer * No prior treatment with oxaliplatin, irinotecan, fluorouracil, or capecitabine * ECOG Performance Status of 0-1 * No other malignancy within past five years (exceptions include basal cell carcinoma of the skin, cervical carcinoma in situ, and non-metastatic prostate cancer) * No evidence of second malignancy at the time of study entry * No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * No \> grade 2 sensory peripheral neuropathy * No uncontrolled seizure disorder, active neurological disease, or known CNS disease * No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment * Not pregnant and not nursing * No other medical condition or reason that, in the opinion of the investigator, would preclude study participation * Laboratory parameters as follows: * Absolute neutrophil count ≥1,500/uL, * Platelet count ≥75,000/uL, * Hemoglobin ≥9 g,/dL, * Creatinine \<1.5 X ULN or estimated GFR \>30 ml/min, * Bilirubin \<1.5 X ULN, * AST and ALT \<3 X ULN, * Negative pregnancy test in women of childbearing potential * Able to be treated with SBRT only at the Smilow New Haven campus * Able to have fiducials placed in the pancreas Exclusion Criteria: * Failing to meet any of the Inclusion Criteria
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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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Yale University School of Medicine
New Haven, Connecticut, 06511, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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