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Compares treatment options for Bone Metastases
Official title A Phase III Randomized Trial Comparing Stereotactic Body Radiation Therapy (SBRT) vs Conventional Palliative Radiation Therapy for Painful Bone Metastases
ClinicalTrials.gov ID: NCT06065449
What this study is testing
What is Radiation Therapy?
Radiation Therapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for bone metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To compare increasing doses and different treatment schedules of stereotactic body radiation therapy (SBRT) against standard treatment scheduling.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patients with pathologic diagnosis of solid primary malignancy with any radiographic report of bone metastases including but not limited to plain...
- Patients with any pain or discomfort at proposed treatment site.
- Patients with life expectancy of 3 months or greater.
- Patients able to complete pain assessment and quality of life surveys.
- Patients with multiple osseous sites are eligible; however, should not treat more than three separate isocenters concurrently. Additional isocenters...
You likely can't join if
- Patients with prior radiation therapy to the proposed treatment site.
- Patient with current, un-treated cord compression at treatment site.
- Patients with a radiographic or pathologic fracture at the proposed treatment site that is not mechanically stable. If this is stabilized...
- Patients with metastases to hand and feet.
- Patients with previously treated with radioactive isotope (e.g. Sr 89) within 30 days of randomization. This can have concomitant effects with...
- Patients with spinal metastases along cervical, thoracic, or lumbar spine are not eligible. However, if the primary site invades the paraspinal or...
See the full eligibility criteria
- Patients with pathologic diagnosis of solid primary malignancy with any radiographic report of bone metastases including but not limited to plain x-ray, bone scan, CT scan, MRI, PET/CT scan, PSMA scan, PET fluciclovine...
- Patients with any pain or discomfort at proposed treatment site.
- Patients with life expectancy of 3 months or greater.
- Patients able to complete pain assessment and quality of life surveys.
- Patients with multiple osseous sites are eligible; however, should not treat more than three separate isocenters concurrently. Additional isocenters can be treated sequentially.
- Patients with prior surgery for osseous metastases are eligible.
- Patients age 18 years or older. Pediatric patients are usually enrolled on pediatric protocols. There are no adverse data available for patients \< 18 years of age treated with SBRT, therefore children are excluded from...
- Patients may receive systemic therapy including chemotherapy, targeted therapy, immunotherapy, or other systemic agents up to and during radiation at treating physician's discretion per standard of care.
- Patients must have adequate organ and marrow function as defined below: platelets ≥ 40,000/mcL
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- The effects of radiation therapy on the developing human fetus are unknown. For this reason and because radiation therapy as well as other therapeutic agents used in this trial are known to be teratogenic, women of...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months)
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian Failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 weeks after completion of radiation therapy.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients with prior radiation therapy to the proposed treatment site.
- Patient with current, un-treated cord compression at treatment site.
- Patients with a radiographic or pathologic fracture at the proposed treatment site that is not mechanically stable. If this is stabilized mechanically or seen by orthopedic surgery, this site is eligible for enrollment...
- Patients with metastases to hand and feet.
- Patients with previously treated with radioactive isotope (e.g. Sr 89) within 30 days of randomization. This can have concomitant effects with radiation therapy.
- Patients with spinal metastases along cervical, thoracic, or lumbar spine are not eligible. However, if the primary site invades the paraspinal or spine region, these are eligible.
- Pregnant patients are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.