About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Palliative radiotherapy
RadiationInitial cohort (stage 1) of patients will receive 4Gy x 2. They will be re-evaluated at 2 and 6 months (+/- 2 weeks). Accounting for anticipated survival times of these patients, we expect to have 12 evaluable patients from 20 enrolled patients. For stage 2 dose reduction will be explored across two palliative regimens, with timepoint for local failure adjusted accordingly.
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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