Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT07039968
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a histologic diagnosis of non-hematopoietic malignancy
2. Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
3. Maximum four separate sites with a maximal involvement of two continuous vertebral levels
4. Patients do not have prior radiotherapy to the index spine(s)
5. Age ≥ 18 years
6. Karnofsky performance status (KPS) ≥ 60%.
7. Life expectancy ≥ 12 months.
8. Women of childbearing potential and male participants must practice adequate contraception
9. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
Exclusion Criteria:
1. Prior radiotherapy or radiosurgery to the index spine(s)
2. Serum creatinine \> 2.0 mg/dL within 90 days prior registration
3. Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
4. Patients with metastatict epidural spinal cord compression (≥ grade 2) at the index spine(s) indicative of upfront spine surgery
5. Inability to tolerate treatment procedure
6. 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 of the protocol, or limit compliance with study requirements, defined as follows:
1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration
2. Transmural myocardial infarction ≤ 6 months prior to registration
3. Unstable angina or congestive heart failure requiring hospitalization ≤ 6 months prior to registration
4. Life-threatening uncontrolled clinically significant cardiac arrhythmias
5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
6. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
7. Uncontrolled psychiatric disorder
7. Will receive any other investigational agent or chemotherapy and/or target therapies during treatment
8. 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 in this study may be significantly teratogenic
9. Pregnant or breast-feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07039968
Study Brief:
Protocol Section:
NCT07039968