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

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05010031

Patient View

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

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.

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