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

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    78
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 12 May 2022

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.

Details
Condition Metastatic Solid Tumors of Metastatic Disease
Treatment radiation therapy, Systemic therapy
Clinical Study IdentifierNCT03523351
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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