Standard versus higher single-dose stereotactic spine radiosurgery for spinal metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label phase II trial assigns adults with non-hematopoietic spinal metastases to one of two single-fraction stereotactic spine radiosurgery (SSRS) doses: standard 16 Gy or high 20 Gy. The study will compare one-year treatment failure rates, safety and toxicity profiles, and effects on pain and quality of life. Eligible participants have up to four spine metastatic sites without intramedullary disease or leptomeningeal involvement and have not received prior radiotherapy to the index spine. Treatment and follow-up occur at National Taiwan University Hospital sites using standardized SSRS planning and outcome assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting
• National Taiwan University Cancer Center
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Feng-Ming Hsu, M.D., Ph.D
• Email: hsufengming@ntuh.gov.tw
• Phone: 886-2-23123456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.