Recruiting NCT05010031
A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palliative radiotherapy.
- Who it may be relevant to
- Registry conditions: Metastatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
Overview
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.
Interventions
- Radiation Palliative radiotherapy
Initial 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.
Primary outcome measures
- Treatment failure rate of irradiated lesion [Time frame: up to 12 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown
- Memorial Sloan Kettering Bergen (All protocol activities) — Montvale
- Memorial Sloan Kettering Commack (All protocol activities) — Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (All protocol activities) — Uniondale
Identifiers
NCT: NCT05010031 · 21-310