A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
- Conditions
- Metastatic Cancer
- Interventions
- Radiation: Palliative radiotherapy
- Registration Number
- NCT05010031
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 29
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description radiation Palliative radiotherapy Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).
- Primary Outcome Measures
Name Time Method Treatment failure rate of irradiated lesion 6 month Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Memorial Sloan Kettering Monmouth (All protocol activities)
🇺🇸Middletown, New Jersey, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Bergen (All protocol activities)
🇺🇸Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (All protocol activities)
🇺🇸Commack, New York, 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, United States