Study Comparing Radiation Therapy to Usual Care for Patients with High-Risk Bone Metastases
Sponsor: NRG Oncology
ClinicalTrials ID:NCT06745024
This clinical trial is exploring whether adding radiation therapy to the usual care can help prevent bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms.
Patient Parameters
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Program Overview
The purpose of this study is to find out if adding radiation therapy to the usual care can better prevent complications like fractures or spinal cord compression in cancer patients with high-risk bone metastases that aren't causing symptoms. High-risk bone metastases are those located in areas like the hip, shoulder, or spine, or those that are 2 cm or larger. Radiation therapy uses high-energy x-rays to kill cancer cells and shrink tumors, and it can be given in one day or spread over up to five days. Usual care might include medications to prevent bone loss or just monitoring the condition until symptoms appear. This study aims to see if radiation therapy can more effectively prevent bone-related issues compared to usual care alone.
Description
PRIMARY OBJECTIVE:
- To find out if radiation therapy can reduce the number of bone-related problems, like fractures or spinal cord compression, in patients with high-risk bone metastases compared to usual care.
SECONDARY OBJECTIVES:
- To compare the overall survival rates between the two groups.
- To compare the occurrence of any bone-related problems, including those needing radiation for pain relief, between the two groups.
- To compare hospitalizations related to bone problems between the two groups.
- To compare the quality of life related to pain between the two groups.
- To assess any side effects of radiation therapy compared to usual care.
EXPLORATORY OBJECTIVES:
- To evaluate overall quality of life and functional status between the two groups.
- To evaluate any hospitalizations for any reason between the two groups.
- To explore differences in outcomes based on race, sex, and health-related needs.
- To assess how different factors like cancer type, treatment, and patient demographics affect the results.
OUTLINE: Patients are randomly assigned to one of two groups.
GROUP I: Patients continue with usual care, which may include cancer treatment or observation, and medications to protect bones. They may also provide blood samples for research.
GROUP II: Patients continue with usual care as in Group I. They also receive radiation therapy once a day for up to five days, unless the disease progresses or side effects are too severe. They will have CT or MRI scans for planning the radiation therapy and may provide blood samples for research.
After completing the study treatment, patients will have follow-up visits at 3, 6, 12, and 24 months.
Eligibility Criteria
Inclusion Criteria
- Have cancer that has spread to more than 5 areas in the body, excluding the brain.
- Have high-risk bone metastases that are not causing symptoms, defined by:
- A large tumor in the bone (2 cm or larger).
- Tumors in the hip, shoulder, or certain spine areas.
- Tumors in long bones affecting up to two-thirds of the bone thickness.
- Tumors in specific spine areas or involving certain spine parts.
- Can have up to 3 high-risk bone metastases included in the study.
- Have any type of solid tumor, except multiple myeloma.
- Have had a recent evaluation of the cancer spread using standard imaging tests.
- Can have treated brain metastases if they were treated before joining the study.
- Be 18 years or older.
- Have a performance status that allows for daily activities with some limitations.
- Have not received radiation therapy to the areas being studied.
- Have no severe spinal cord compression at the areas being studied.
- Have no previous fractures at the areas being studied.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| Mission Hope Medical Oncology - Arroyo Grande | 93420 | Arroyo Grande | California |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | 95603 | Auburn | California |
| AIS Cancer Center at San Joaquin Community Hospital | 93301 | Bakersfield | California |
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