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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Palliative radiotherapy

    Radiation

    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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: radiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
up to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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