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A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change

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: NCT05010031
Recruitment Status : Recruiting
First Posted : August 18, 2021
Last Update Posted : September 23, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
This study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Radiation: Palliative radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, phase II noninferiority, prospective trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: radiation
Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).
 Radiation: Palliative radiotherapy
The first cohort of 26 evaluable patients will be treated with 4Gyx2, followed by a 6 month observation period post-RT to assess for treatment failures. If 7 or more failures are observed, cohort 1 will be closed and 4Gyx3 will be explored in the second cohort. If at most 6 failures are detected in the first cohort, dose will be further reduced to 4Gyx1 for the second cohort. Radiation therapy will be delivered according to department standards, including normal tissue constraints per hypofractionated guidelines. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment failure rate of irradiated lesion [ Time Frame: 6 month ]
    Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST


Eligibility Criteria
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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 confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy
  • Pathogenic mutation in ATM (somatic and germline allowed)
  • ECOG performance status 0-2
  • Age ≥ 18 years.
  • Able to provide informed consent.
  • Patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments.
  • Expected life expectancy of at least 6 months

Exclusion Criteria:

  • Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
  • Serious medical co-morbidities precluding radiotherapy.
  • Pregnant or breast-feeding women.
  • Concomitant pathogenic mutation in p53
  • Lesions excluded from de-escalation include regions in which the risk of local disease progression is unacceptably high, including CNS disease and cord compression, and areas in which re-irradiation would not be feasible, including spinal cord overlap.
Contacts and Locations
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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): NCT05010031


Contacts
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Contact: Amy Xu, MD, PhD 646-888-6863 xua@mskcc.org
Contact: Daniel Gomez, MD 212-639-2087

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (All Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 10065
Contact: Amy Xu, MD, PhD    646-888-6863      
Memorial Sloan Kettering Monmouth (All protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Amy Xu, MD, PhD    646-888-6863      
Memorial Sloan Kettering Bergen (All protocol activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Amy Xu, MD, PhD    646-888-6863      
United States, New York
Memorial Sloan Kettering Commack (All protocol activities) Recruiting
Commack, New York, United States, 11725
Contact: Amy Xu, MD, PhD    646-888-6863      
Memorial Sloan Kettering Westchester (All Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Amy Xu, MD, PhD    646-888-6863      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Amy Xu, MD, PhD    646-888-6863      
Contact: Daniel Gomez, MD    212-639-2087      
Principal Investigator: Amy Xu, MD, PhD         
Memorial Sloan Kettering Nassau (All protocol activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Amy Xu, MD, PhD    646-888-6863      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Amy Xu, MD, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05010031    
Other Study ID Numbers: 21-310
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
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: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Reduced-dose Radiation
Pathogenic Mutations
ATM (ataxia telangiectasia mutated)
21-310
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes