Metastatic Cancer Clinical Trial
Official title:
Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
| NCT number | NCT05010031 |
| Other study ID # | 21-310 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | August 11, 2021 |
| Est. completion date | August 2026 |
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.
| Status | Recruiting |
| Enrollment | 29 |
| Est. completion date | August 2026 |
| Est. primary completion date | August 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Basking Ridge | 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 Monmouth (All protocol activities) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen (All protocol activities) | Montvale | New Jersey |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment failure rate of irradiated lesion | Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST | 6 month |
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