NCT05010031 A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
| NCT ID | NCT05010031 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Metastatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2021-08-11 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2021-08-11 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Amy Xu, MD, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05010031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05010031 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05010031 currently recruiting?
Yes, NCT05010031 is actively recruiting participants. Contact the research team at xua@mskcc.org for enrollment information.
Where is the NCT05010031 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT05010031 clinical trial?
NCT05010031 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Amy Xu, MD, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 45 participants.
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