Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 45
- Locations
- 7
- Primary Endpoint
- Treatment failure rate of irradiated lesion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
radiation
Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases). The study uses a prespecified 2-stage design with early stopping after the first stage to evaluate whether treatment-failure rates are acceptably low relative to a historical benchmark.
Intervention: Palliative radiotherapy (Radiation)
Outcomes
Primary Outcomes
Treatment failure rate of irradiated lesion
Time Frame: 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 Outcomes
No secondary outcomes reported