Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatment in Patients With Locally Advanced Pancreatic Cancer (MAIBE)

May 1, 2026 updated by: Memorial Sloan Kettering Cancer Center

Maximal Ablative Irradiation Because of Encasement (MAIBE) for Patients With Potentially Resectable Locally Advanced Pancreatic Cancer

This study is being done to test whether receiving a dose of radiation that is higher than the standard dose, in combination with chemotherapy, improves the chance of becoming a candidate for surgery and improves the chance of extending the patient's life.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Rockville Centre
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HFA-IMRT
Eligible patients will receive HFA-IMRT to a total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions to areas of gross tumor with concurrent capecitabine. Cross-sectional imaging will be repeated 4-6 weeks after the end of CRT to assess for resectability.
Radiation: Hypofractionated ablative IMRT (HFA-IMRT)
total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions
Drug: capecitabine
Oral capecitabine at 825 mg/m2 BID on the days of RT. 5 Fluorouracil (5FU) at 250mg/m2/day, 7 days per week by a continuous IV infusion via an outpatient infusion pump) may be used instead at the discretion of the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients who undergo definitive surgery
Time Frame: 2 years
The proportion of patients who undergo definitive surgery will be used to evaluate efficacy of HFA-IMRT in improving rates of resectability as compared to historical controls.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Marsha Reyngold, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2018

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-090

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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