Enrollment complete
Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)
NCT No.: NCT06745024
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym:
Official Title
Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)
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). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.
Detailed Description
Eligibility Criteria
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) (Brief Pain Inventory [BPI] score of < 5 on the "maximum" pain item) defined as fulfilling at least one of the following four high-risk criteria:
* Bulky site of disease in bone ( ≥ 2 cm);
* Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints;
* Disease in long bones occupying up to 2/3 of the cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges); and/or
* 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
* 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 positron emission tomography (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: Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status (KPS) ≥ 60
* No previous radiotherapy to the intended enrolled sites of disease
* No epidural spinal cord compression (ESCC) ≥ grade 1c (defined as deformation of the thecal sac with spinal cord abutment) at the enrolled bone metastasis(es)
* No prior fracture at the enrolled bone metastasis(es)
|
Exclusion Criteria
Keywords and/or Specific Medical Conditions
|
|
- Neoplasm Metastasis, Neoplastic Processes, Neoplasms, Pathologic Processes, Pathological Conditions, Signs and Symptoms
|
Sponsors
|