BridgeMD
Compares treatment options for Spinal Neoplasms
Official title Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms
ClinicalTrials.gov ID: NCT07039968
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if a higher dose of Stereotactic Spine Radiosurgery (SSRS), an advanced radiation technique, is better for treating cancer that has spread to the spine (spinal metastases). The study will also learn about the safety of using a higher dose.
- Phase 2: a mid-size study of how well it works
- 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
You may be able to join if
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum four separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Age ≥ 18 years
You likely can't join if
- Prior radiotherapy or radiosurgery to the index spine(s)
- Serum creatinine \> 2.0 mg/dL within 90 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with metastatict epidural spinal cord compression (≥ grade 2) at the index spine(s) indicative of upfront spine surgery
- Inability to tolerate treatment procedure
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere...
See the full eligibility criteria
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum four separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 60%.
- Life expectancy ≥ 12 months.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
- Prior radiotherapy or radiosurgery to the index spine(s)
- Serum creatinine \> 2.0 mg/dL within 90 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with metastatict epidural spinal cord compression (≥ grade 2) at the index spine(s) indicative of upfront spine surgery
- Inability to tolerate treatment procedure
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events...
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
- Transmural myocardial infarction ≤ 6 months prior to registration
- Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
- Life-threatening uncontrolled clinically significant cardiac arrhythmias
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Uncontrolled psychiatric disorder
- Will receive any other investigational agent or chemotherapy and/or target therapies during treatment
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved...
- Pregnant or breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. 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.