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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523312
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Hypofractionated ablative IMRT (HFA-IMRT) Drug: capecitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This phase II trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maximal Ablative Irradiation Because of Encasement (MAIBE) for Patients With Potentially Resectable Locally Advanced Pancreatic Cancer
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523312


Contacts
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Contact: Marsha Reyngold, MD, PhD 631-623-4267 reyngolm@mskcc.org
Contact: Christopher Crane, MD 646-888-5208

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Marsha Reyngold, MD, PhD    631-623-4267      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Marsha Reyngold, MD, PhD    631-623-4267      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Marsha Reyngold, MD, PhD    631-623-4267      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Marsha Reyngold, MD, PhD    631-623-4267      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Marsha Reyngold, MD, PhD    631-623-4267      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Marsha Reyngold, MD, PhD    631-623-4267      
Contact: Christopher Crane, MD    646-888-5208      
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Marsha Reyngold, MD, PhD    631-623-4267      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Marsha Reyngold, MD,PhD    631-623-4267      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Marsha Reyngold Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03523312    
Other Study ID Numbers: 18-090
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020

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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
Keywords provided by Memorial Sloan Kettering Cancer Center:
Ablative Irradiation
18-090
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents