RADIATION THERAPY FOR HIGH-RISK ASYMPTOMATIC BONE METASTASES: A PRAGMATIC MULTICENTER RANDOMIZED PHASE 3 CLINICAL TRIAL (PREEMPT)
Investigating Radiation Therapy for High-Risk Asymptomatic Bone Metastases (cancer that has spread to other parts of the body)
Arpan Prabhu
Primary Investigator
Brief description of study
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 of study
Patients are randomized to 1 of 2 arms.
ARM I: Patients continue to receive SOC systemic anti-cancer therapy or observation and bone modifying agents as determined by the treating physician. Additionally, patients undergo optional blood sample collection on study.
ARM II: Patients continue SOC as in Arm I. Patients also undergo conventional RT or stereotactic body radiation therapy (SBRT) once daily (QD) for up to 5 days (5 fractions) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and optional blood sample collection on study.
After completion of study treatment, patients are followed up at 3, 6, 12 and 24 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Metastatic Malignant Neoplasm in the Bone, Cancer
-
Age: 18 years - 100 years
-
Gender: All
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 (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
- NOTE: 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)
- "High-risk" asymptomatic bone metastasis (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:
This study investigates the effect of adding radiation therapy to usual care for patients with high-risk asymptomatic bone metastases. Bone metastases are cancer cells that have spread to the bones. High-risk means they are more likely to cause problems like fractures or pain. Radiation therapy uses powerful x-rays to kill cancer cells and shrink tumors. This study aims to see if radiation therapy can prevent bone problems better than usual care alone.
In this study, patients are divided into two groups, called study arms. In Arm I, patients receive their usual cancer treatment along with any necessary bone-strengthening medications. In Arm II, patients receive the same care as Arm I, but also undergo radiation therapy for up to five days. Some patients may also have blood samples taken, and imaging tests like CT or MRI scans to check their progress.
- Who can participate: Adults aged 18 and older with more than 5 sites of cancer spread to the bones, except for brain cancer, can participate. Participants must have high-risk asymptomatic bone metastases and meet specific health criteria, including a performance status of ECOG (a scale to assess how a patient is functioning) 0-2 or KPS (a scale to assess a patient's ability to perform daily activities) ≥ 60.
- Study details: Participants will either continue their regular cancer care or receive additional radiation therapy. Some will also have blood samples taken and imaging tests like CT (a type of imaging scan) or MRI (a type of imaging scan). Radiation therapy involves using x-rays to target cancer cells.
Find a site
,
Send a message
Enter your contact details to connect with study team
Primary Contact
