Study of Palliative Radiation Therapy vs. no Palliative Radiation Therapy for Patients With High Risk Bone Metastases That Are Not Causing Significant Pain

Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

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 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.

Arm && Interventions

Group	Intervention	Description
Selective radiation to ≤5 highest risk bone metastases	Radiation Therapy	Patients on Arm 2 of the study will undergo selective RT to ≤ 5 high risk bone metastases 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) \&/or disease with posterior element involvement.
Standard of care	Systemic Therapy	Patients randomized to Arm 1 will undergo appropriate therapy as determined by their oncologist. These patients will either continue their current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to Arm 1, these patients may undergo palliative RT for progressive, painful lesions (a skeletal related event) at time of symptom development (not upfront palliative RT).

Primary Outcome Measures

Name	Time	Method
number of patients who have skeletal related events (SREs)	2 years	which will be defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.

Secondary Outcome Measures

Name	Time	Method

Locations (9): Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Basking Ridge
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Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen
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Montvale, New Jersey, United States
Baptist Alliance Miami Cancer Institute
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Miami, Florida, United States
Memorial Sloan Kettering Commack
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Commack, New York, United States
Memorial Sloan Kettering Westchester
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Harrison, New York, United States
Lehigh Valley Health Network
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Allentown, Pennsylvania, United States
Memorial Sloan Kettering Nassau
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Uniondale, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States