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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Enrolling
Phase 2

Conditions

Metastatic Cancer

Treatments

Radiation: Palliative radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

radiation
Experimental group
Description:
Subjects will receive reduced dose radiation to radiographically progressive lesions identified on imaging (including asymptomatic bone metastases).
Treatment:
Radiation: Palliative radiotherapy

Trial contacts and locations

7

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Central trial contact

Daniel Gomez, MD; Amy Xu, MD, PhD

Data sourced from clinicaltrials.gov

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