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

Memorial Sloan Kettering Cancer Center78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Metastatic Solid Tumors of Metastatic Disease

Interventions

Radiation TherapyRADIATION

Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.

Systemic TherapyDRUG

Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

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

Outcomes

Primary Outcomes

Number of Participants With Skeletal Related Events (SREs)

which will be defined as pathological fractures, spinal cord compression, or palliative radiotherapy and orthopedic surgery to bone.

Time frame: 1 year

Data from ClinicalTrials.gov

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