A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
NCT ID: NCT05010031
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
29 participants
INTERVENTIONAL
2021-08-11
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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radiation
Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).
Palliative radiotherapy
An initial cohort of 12 evaluable patients will be treated with 4Gyx2, with adaptive dosing planned for expansion cohorts pending the number of failures observed after 6 month observation of the initial cohort.
Interventions
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Palliative radiotherapy
An initial cohort of 12 evaluable patients will be treated with 4Gyx2, with adaptive dosing planned for expansion cohorts pending the number of failures observed after 6 month observation of the initial cohort.
Eligibility Criteria
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Inclusion Criteria
* 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
* Serious medical co-morbidities precluding radiotherapy.
* Pregnant or breast-feeding women.
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Amy Xu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Daniel Gomez, MD
Role: CONTACT
Facility Contacts
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Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Amy Xu, MD, PhD
Role: primary
Daniel Gomez, MD
Role: backup
Amy Xu, MD, PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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21-310
Identifier Type: -
Identifier Source: org_study_id
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