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Lay Description

This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger).

Category

  • Cancers and Other Neoplasms
  • Muscle, Bone and Cartilage
IRB Number
STUDY00001813
NCT Number
NCT # not yet entered

Eligibility

Eligible Ages
18 and Older
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Patients with polymetastatic cancer defined as more than 5 sites of radiographically evident systemic metastatic disease (excluding intracranial disease). “High-risk” asymptomatic bone metastasis(es) (BPI score of < 5 on the “maximum” pain item) defined as fulfilling at least one of the following four high-risk criteria: 1. Bulky site of disease in bone (≥ 2 cm); 2. Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints; 3. Disease in long bones occupying up to 2/3 of the cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges); and/or 4. Disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterolateral element (pedicles and/or facet joints) involvement. NOTES: Patients may have up to 3 individual high-risk bone metastases enrolled in the study. Sternum, rib, and scapula are defined as flat bones so lesions in these locations would only be included if bulky (per high-risk criteria #1). Patients with any solid tumor type (excluding multiple myeloma). Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body PET/CT, with radiology report available. Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment. Age ≥ 18. Performance Status: ECOG 0-2 or KPS ≥ 60. 

Exclusion Criteria

A patient cannot be considered eligible for this study unless ALL of the following inclusion conditions are met.

Study Design

Arm Groups

Study Contact


Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu

Principal Investigator
Shraddha Dalwadi