Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain
Completed · Phase 1/Phase 2
Conditions studied: Metastatic Solid Tumors of Metastatic Disease
In brief
The purpose of the study is to compare the outcome of patients who receive standard treatment versus those who receive preventative radiation and then standard treatment.
Key facts
- Study ID
- NCT03523351
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 78
- Starts
- 2018-05-01
- Expected to finish
- 2024-04-18
- Last updated by the study team
- 2025-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on imaging.
- Has high risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risks metastases are defined as: 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterior element involvement.
- 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. Women of childbearing potential must not be pregnant or lactating.
You may not qualify if…
- 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 lactating women.
- Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
- Leptomeningeal disease.
- Malignant pleural effusion.
- Absolute neutrophil count (ANC) <1.0 K/mcL and platelet count <50 K/mcL at time of enrollment.
- Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
Where it is running
- Baptist Alliance Miami Cancer Institute — Miami, Florida, United States
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack — Commack, New York, United States
- Memorial Sloan Kettering Westchester — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Memorial Sloan Kettering Nassau — Uniondale, New York, United States
- Lehigh Valley Health Network — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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