Recruiting
Phase 2

Reduced-dose Radiation

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05010031

Conditions

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Palliative radiotherapy

Study Details

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.

Conditions

Metastatic Cancer

Study ID

NCT05010031

Start date

Aug 11, 2021

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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 measure

  • Treatment failure rate of irradiated lesion [ Time Frame: up to 12 months ]

Central Contacts and Locations

Central contacts

Amy Xu, MD, PhD

646-888-6863xua@mskcc.org

Daniel Gomez, MD

212-639-2087

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 10065

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Monmouth (All protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Bergen (All protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Commack (All protocol activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Amy Xu, MD, PhD

646-888-6863

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Amy Xu, MD, PhD

646-888-6863

Daniel Gomez, MD

212-639-2087

Principal Investigator:

Amy Xu, MD, PhD

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Amy Xu, MD, PhD

646-888-6863

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-11.