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Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors

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: NCT04343573
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy.

Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.


Condition or disease Intervention/treatment Phase
Leptomeningeal Metastases Radiation: Involved-field Photon Radiation Therapy Radiation: Proton Craniospinal Irradiation (CSI) Phase 2

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Study Type : Interventional
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized (2:1) phase II multicenter trial in patients with leptomeningeal metastases from NSCLC and breast cancer.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study Assessing the Efficacy of Proton Craniospinal Irradiation (CSI) vs Involved-field Photon Radiation Therapy for Leptomeningeal Metastases From Solid Tumor Malignancies
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
Experimental: Proton CSI Followed by Standard of Care (NSCLC & Breast)
Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
Radiation: Proton Craniospinal Irradiation (CSI)
Proton CSI (30Gy [RBE] in 10 fractions)

Experimental: Standard of Care
Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
Radiation: Involved-field Photon Radiation Therapy
Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions)

Proton CSI Followed by Standard of Care (Other Solid Tumors)
(Exploratory arm) Patients with solid tumor malignancies other than NSCLC or breast cancer will be enrolled to the exploratory proton CSI arm (Arm C) and will not undergo randomization. Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
Radiation: Proton Craniospinal Irradiation (CSI)
Proton CSI (30Gy [RBE] in 10 fractions)




Primary Outcome Measures :
  1. CNS progression free survival [ Time Frame: 2 years ]
    Forr Arm A and Arm B, which will be defined as the duration of time from the date of randomization to the time of progression of disease or death, whichever occurs first. The baseline imaging study will be the diagnostic imaging obtained at study entry.


Secondary Outcome Measures :
  1. overall survival (OS) (Arm A and Arm B) [ Time Frame: 2 years ]
    will be included in an analysis of overall survival, defined as time from randomization to death.



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:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology
  • Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
  • Patients of all ages
  • KPS ≥ 60 for participants ≥ 16 years old, and Lansky ≥ 60 for participants < 16 years old
  • For adult patient, the patient/ legally authorized representative is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
  • Adequate bone marrow function:

    • Hemoglobin > 8g/dL
    • Absolute neutrophil count >1,000/mm
    • Platelet count > 100,000/mm
  • Female subjects must either be of non-reproductive potential (i.e. pediatric patients, OR postmenopausal by history [≥ 60 years old, or with no menses for >1 year without an alternative medical cause], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
  • Patient at reproductive potential must agree to practice an effective contraceptive method.

Exclusion Criteria:

  • Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
  • Patient with extensive systemic disease and without reasonable systemic treatment options
  • Patient who is unable to undergo MRI brain and spine with gadolinium contrast
  • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
  • Pregnant or lactating women.

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): NCT04343573


Contacts
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Contact: T. Jonathan Yang, MD, PhD 212-639-8157 yangt@mskcc.org
Contact: Adrienne Boire, MD, PhD 646-888-3786

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: T. Jonathan Yang, MD, PhD    212-639-8157      
Memorial Sloan Kettering Monmouth (Limitedl protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: T. Jonathan Yang, MD, PhD    212-639-8157      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: T. Jonathan Yang, MD, PhD    212-639-8157      
United States, New York
Memorial Sloan Kettering Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: T. Jonathan Yang, MD, PhD    212-639-8157      
Memoral Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: T. Jonathan Yang, MD, PhD    212-639-8157      
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Stanislav Lazarev, MD    212-241-7500      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: T. Jonathan Yang, MD, PhD    212-639-8157      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: T. Jonathan Yang, MD    212-639-8157      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: T. Jonathan Yang, MD, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04343573    
Other Study ID Numbers: 20-117
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Proton Craniospinal Irradiation (CSI)
Involved-field Photon Radiation Therapy
20-117
Additional relevant MeSH terms:
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Neoplasm Metastasis
Meningeal Carcinomatosis
Neoplastic Processes
Neoplasms
Pathologic Processes
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases