Blasting pancreatic tumors with extra radiation may open door to surgery
NCT ID NCT03523312
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving a higher-than-standard dose of radiation, along with chemotherapy, can shrink pancreatic tumors enough to make them removable by surgery. The study includes 47 people with locally advanced pancreatic cancer that currently cannot be surgically removed. The goal is to see if this approach increases the number of patients who can undergo surgery and potentially live longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (hypofractionated ablative IMRT) and chemotherapy (capecitabine or 5-fluorouracil)
- What this could lead to
- If it works, this could help more people with locally advanced pancreatic cancer become eligible for surgery, which may improve survival.
- What could go wrong
- This is a small, early-phase trial with only 47 participants, so results may not apply to everyone. Higher radiation doses also carry increased risks of side effects.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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47 people
The number who actually took part.
- Started
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Apr 2018
- Expected to finish
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Apr 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: * Histologically or cytopathologically confirmed adenocarcinoma of the pancreas. * Locally advanced, unresectable pancreatic cancer defined on post-induction chemotherapy CT as having tumor involvement of \>180° (\> 50%) of the circumference of the superior mesenteric artery (SMA) or celiac axis, unreconstructable superior mesenteric vein (SMV) or PV involvement. * No evidence of distant metastasis either prior to or after induction chemotherapy. * Completion of at least 3 months of standard induction chemotherapy for LAPC, which may include FOLFIRINOX or gemcitabine and nab-paclitaxel, within 6 weeks of enrollment. * For patients currently receiving investigational agents, a washout of at least 2 weeks or 5 half-lives of experimental agent are required prior to the start of RT. * Age ≥18 years. * KPS 70-100. * Patients must have acceptable organ and marrow function as defined below: * Leukocytes \>3,000/µL * Absolute neutrophil count \>1,500/µL * Platelets \>75,000/µL * Total bilirubin Within 2 x upper limit of normal * AST (SGOT)/ALT (SGPT) \<2.5 x institutional upper limit of normal Creatinine Within 1.5 x upper limit of normal, OR Creatinine clearance \>60 mL/min for patients with creatinine levels above institutional normal * Any systemic therapy associated toxicity should be Grade 1 or less * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have borderline resectable disease using NCCN definition. * Patients who have had prior abdominal radiotherapy. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * Patients who are not surgical candidates due to medical co-morbidities. * Patients in whom iodine contrast is contraindicated. * Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. This applies to any woman who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months, or women on hormone replacement therapy with serum FSH levels greater than 35 mIU/mL. A negative serum pregnancy test must be obtained within 14 days prior to the start of study therapy in all women of child-bearing potential. Male subjects must also agree to use effective contraception for the same period as above.
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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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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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