A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change

Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05010031

Enrollment

Registered

2021-08-18

Start date

2021-08-11

Completion date

2027-08-01

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer

Keywords

Reduced-dose Radiation, Pathogenic Mutations, ATM (ataxia telangiectasia mutated), 21-310

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.

Interventions

RADIATIONPalliative radiotherapy

An initial cohort of 12 evaluable patients will be treated with 4Gyx2, with adaptive dosing planned for expansion cohorts pending the number of failures observed after 6 month observation of the initial cohort.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Single arm, phase II noninferiority, prospective trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

CONTACTAmy Xu, MD, PhD

xua@mskcc.org646-888-6863

CONTACTDaniel Gomez, MD

212-639-2087

PRINCIPAL_INVESTIGATORAmy Xu, MD, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026