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NCT05010031PHASE2Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

8/11/2021

Completion Date

8/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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. * 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.

Interventions

RADIATION

Palliative radiotherapy

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Conditions

Metastatic Cancer

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey 10065

United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Commack (All protocol activities)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York 11553

United States