Pancreatic CancerPhase 2MAIBENCT03523312
Use of High-dose Radiation Therapy Plus Chemotherapy to Improve the Likelihood of Surgical Treatment in Patients With Locally Advanced Pancreatic Cancer
A Phase 2 study testing Hypofractionated ablative IMRT (HFA-IMRT) and capecitabine in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Hypofractionated ablative IMRT (HFA-IMRT) and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Apr 2018to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Hypofractionated ablative IMRT (HFA-IMRT), capecitabine
- Keywords
- Ablative Irradiation, 18-090
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated ablative IMRT (HFA-IMRT)Radiation
total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions
capecitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HFA-IMRT | Experimental | 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. Receives: Radiation: Hypofractionated ablative IMRT (HFA-IMRT); Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who undergo definitive surgery
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start30 Apr 2018
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This phase II trial.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marsha Reyngold, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523312
- Sponsor's protocol ID
- 18-090
- Acronym
- MAIBE
- Status last verified
- May 2026
- First submitted
- 1 May 2018
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Reyngold M, Wei AC, O'Reilly EM, D'Angelica MI, Kingham TP, Soares KC, Varghese AM, White C, Zinovoy M, Romesser PB, Wu A, Hajj C, Cuaron JJ, Khalil DN, Balogun F, Park W, Yu KH, Balachandran VP, Drebin JA, Lagratta M, Zhang Z, Jarnagin WR, Crane CH. Maximal Ablative Irradiation Because of Encasement for Patients With Locally Advanced Pancreatic Cancer: A Nonrandomized Clinical Trial. JAMA Surg. 2026 Jul 29:e262988. doi: 10.1001/jamasurg.2026.2988. Online ahead of print.
PubMed 42525419
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Ablative Irradiation Because of Encasement (MAIBE) for Patients With Potentially Resectable Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03523312
- Acronym / sponsor ID
- MAIBE / 18-090
- Conditions
- Pancreatic Cancer
- Keywords
- Ablative Irradiation, 18-090
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This phase II trial.
| Arm | Type | Receives |
|---|---|---|
| HFA-IMRT | Experimental | Radiation: Hypofractionated ablative IMRT (HFA-IMRT), Drug: capecitabineEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated ablative IMRT (HFA-IMRT)total dose of 67.5 Gy in 15 fractions or 75Gy in 25 fractions | Radiation | HFA-IMRT |
| capecitabineOral 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. | Drug | HFA-IMRT |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 42525419Reyngold M, Wei AC, O'Reilly EM, D'Angelica MI, Kingham TP, Soares KC, Varghese AM, White C, Zinovoy M, Romesser PB, Wu A, Hajj C, Cuaron JJ, Khalil DN, Balogun F, Park W, Yu KH, Balachandran VP, Drebin JA, Lagratta M, Zhang Z, Jarnagin WR, Crane CH. Maximal Ablative Irradiation Because of Encasement for Patients With Locally Advanced Pancreatic Cancer: A Nonrandomized Clinical Trial. JAMA Surg. 2026 Jul 29:e262988. doi: 10.1001/jamasurg.2026.2988. Online ahead of print.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marsha Reyngold principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated ablative IMRT (HFA-IMRT) and capecitabine in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who undergo definitive surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.