A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT05010031
This study evaluates the efficacy of reduced-dose radiotherapy in patients with metastatic tumors and ATM mutations. Eligible participants must have a confirmed malignancy, be 18 or older, and meet specific health criteria. The intervention involves an initial cohort receiving 4Gyx2 radiation, with adaptive dosing based on outcomes after six months.
Patient Parameters
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Program Overview
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
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | 10065 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (All protocol activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (All protocol activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Commack (All protocol activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (All Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (All protocol activities) | 11553 | Uniondale | New York |
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