Active (not recruiting)
Phase 3
NCT06745024
Comparing Radiation Therapy to Usual Treatment for Patients With High-Risk Bone Metastases That Are Not Causing Pain, PREEMPT Trial
Phase 3 – large-scale trial before approval
Conditions:
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Solid Neoplasm
NRG Oncology
trial.available_in:
This phase III trial compares the effect of adding radiation therapy to usual treatment on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms, such as pain (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 treatment 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 treatment may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.
PRIMARY OBJECTIVE:
I. To determine whether prophylactic radiation therapy (RT) to high-risk asymptomatic bone metastases decreases the occurrence of skeletal-related events (SREs), including pathologic fracture, spinal cord compression, and surgery to bone (not including palliative radiation for pain only), compared to standard of care (SOC).
SECONDARY OBJECTIVES:
I. To compare overall survival (OS) between study arms. II. To compare occurrence of any SREs (including RT for palliation of pain) among enrolled bone metastasis(es) between study arms.
III. To compare occurrence of hospitalizations related to any SREs in enrolled bone metastasis(es) between study arms.
IV. To compare pain-related quality of life (QOL) between study arms. V. To characterize adverse events of RT and compare to SOC.
EXPLORATORY OBJECTIVES:
I. To evaluate overall QOL, functional status, and quality-adjusted life years between study arms.
II. To evaluate any hospitalizations (from any cause) between study arms. III. To characterize differences in primary and secondary endpoints between study arms (a) among the represented racial and ethnic groups (e.g. Black, White, Hispanic/Latino, Asian/Pacific Islander, and Native American), (b) by sex, and (c) by health-related social needs.
IV. To evaluate the heterogeneity of radiation treatment effect based on cancer-related factors (histology, criteria indicating high-risk for SRE), treatment-related factors (bone modifying agent use, radiation dose/technique), and patient demographic factors (age, sex, race, ethnicity, and health-related social needs).
OUTLINE: 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) for RT planning and optional blood sample collection on study.
After completion of study treatment, patients are followed up at 3, 6, 12 and 24 months.
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) (defined as pain score of \< 5 on a 0-10 scale using question #3 from the Brief Pain Inventory \[BPI\]) 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 (per high-risk criteria #1)
* Question #3 from the Brief Pain Inventory (BPI): "On a scale of 0-10, 0 being no or least amount of pain, and 10 being the worst pain imaginable, what score would you rate your worst pain in the last 24 hours."
* The pain score can be lesion-specific and does not need to refer to overall pain.
* The remaining questions on the BPI are not required to confirm eligibility
* Patients with any solid tumor type (excluding multiple myeloma and lymphoma)
* 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)
Biospecimen Collection
PROCEDURE
Bone Metastases Treatment
OTHER
Computed Tomography
PROCEDURE
Conventional Radiotherapy
PROCEDURE
Magnetic Resonance Imaging
PROCEDURE
Patient Observation
OTHER
Questionnaire Administration
OTHER
Stereotactic Body Radiation Therapy
RADIATION
627
(2)
The Research Institute of the McGill University Health Centre (MUHC)
University Health Network-Princess Margaret Hospital
(625)
Hawaii Cancer Care - Westridge
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