RECRUITING

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

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Conditions

Metastatic CancerReduced-dose RadiationPathogenic MutationsATM (ataxia telangiectasia mutated)21-310

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-08-11
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05010031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy
  2. * Pathogenic mutation in ATM (somatic and germline allowed)
  3. * ECOG performance status 0-2
  4. * Age ≥ 18 years.
  5. * Able to provide informed consent.
  6. * Patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments.
  7. * Expected life expectancy of at least 6 months
  1. * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
  2. * Serious medical co-morbidities precluding radiotherapy.
  3. * Pregnant or breast-feeding women.
  4. * 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.

Contacts and Locations

Study Contact

Amy Xu, MD, PhD
CONTACT
646-888-6863
xua@mskcc.org
Daniel Gomez, MD
CONTACT
212-639-2087

Principal Investigator

Amy Xu, MD, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 10065
United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Amy Xu, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-11
Study Completion Date2026-08

Study Record Updates

Study Start Date2021-08-11
Study Completion Date2026-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Metastatic Cancer