Purpose

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

IRB Number
STUDY00001813
NCT Number
-
Sponsor
-



Study Contact

Principal Investigator
Shraddha Dalwadi

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



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

A Pragmatic Multicenter Randomized Phase 3 Clinical Trial.

Arm Groups