Clinical Trials /

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

NCT05010031

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT05010031

Trial Eligibility

Document

Title

  • Brief Title: A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
  • Official Title: Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM

Clinical Trial IDs

  • ORG STUDY ID: 21-310
  • NCT ID: NCT05010031

Conditions

  • Metastatic Cancer

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
radiationExperimentalSubjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).

    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.

          -  Concomitant pathogenic mutation in p53

          -  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.
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Treatment failure rate of irradiated lesion
    Time Frame:6 month
    Safety Issue:
    Description:Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

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

    Last Updated

    August 18, 2021