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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05010031
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 11, 2021
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey10065
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Monmouth (All protocol activities)MiddletownNew Jersey07748
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Bergen (All protocol activities)MontvaleNew Jersey07645
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Commack (All protocol activities)CommackNew York11725
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Amy Xu, MD, PhD
646-888-6863
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Amy Xu, MD, PhD
646-888-6863
Daniel Gomez, MD
212-639-2087
Amy Xu, MD, PhD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (All protocol activities)UniondaleNew York11553
Amy Xu, MD, PhD
646-888-6863

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All protocol activities)· Middletown, NJMemorial Sloan Kettering Bergen (All protocol activities)· Montvale, NJMemorial Sloan Kettering Commack (All protocol activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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