Clinical Trial Radar

Name: Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
Creator: Memorial Sloan Kettering Cancer Center
Published: 2021-08-18
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT05010031 for Metastatic Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change Phase 2 40

Recruiting

Clinical Trial NCT05010031 is designed to study Treatment for Metastatic Cancer. It is a Phase 2 interventional study that is recruiting, having started on August 11, 2021, with plans to enroll 40 participants. Led by Memorial Sloan Kettering Cancer Center, it is expected to complete by August 1, 2027. The latest data from ClinicalTrials.gov was last updated on January 23, 2026.

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.

Official Title

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

Conditions

Metastatic Cancer

Other Study IDs

21-310

NCT ID Number

NCT05010031

Start Date (Actual)

2021-08-11

Last Update Posted

2026-01-23

Completion Date (Estimated)

2027-08

Enrollment (Estimated)

Study Type

Interventional

PHASE

Phase 2

Status

Recruiting

Keywords

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

Primary Purpose

Treatment

Design Allocation

N/A

Interventional Model

Single Group

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Experimentalradiation Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).	Palliative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 month

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

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.

Memorial Sloan Kettering Cancer Center

Study Central Contact

Contact: Amy Xu, MD, PhD, 646-888-6863, [email protected]

Contact: Daniel Gomez, MD, 212-639-2087

7 Study Locations in 1 Countries

United States

New Jersey

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 10065, United States