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



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:April 30, 2018
End Date:April 2020
Contact:Marsha Reyngold, MD, PhD
Email:reyngolm@mskcc.org
Phone:631-623-4267

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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.


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.
We found this trial at
8
sites
136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
Phone: 631-623-4267
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Commack, New York 11725
Phone: 631-623-4267
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Commack, NY
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500 Westchester Avenue
Harrison, New York 10604
Phone: 631-623-4267
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Harrison, NY
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480 Red Hill Road
Middletown, New Jersey 07748
Phone: 631-623-4267
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 631-623-4267
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 631-623-4267
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rockville Centre, New York 11570
Phone: 631-623-4267
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Rockville Centre, NY
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Uniondale, New York 11553
Phone: 631-623-4267
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Uniondale, NY
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