Standard versus higher single-dose stereotactic spine radiosurgery for spinal metastases
Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms - SHINE: A Prospective Randomized Trial
This trial will see if a higher single dose (20 Gy) of focused spine radiosurgery, compared with the standard single dose (16 Gy), reduces treatment failures and keeps side effects acceptable for people with spinal metastases.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Taipei and 1 other locations) |
| Trial ID | NCT07039968 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with non-hematopoietic cancer who have 1–4 localized spine metastases (maximum two contiguous vertebral levels), no prior radiotherapy to the index spine, KPS ≥ 60, and an expected survival of at least 12 months are ideal candidates.
Not a fit: Patients with epidural spinal cord compression, intramedullary lesions, prior radiation to the index spine, contraindications to MRI, or very limited life expectancy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, a higher single SSRS dose could provide more durable tumor control in the spine and reduce the need for repeat treatments while maintaining acceptable side effects.
How similar studies have performed: Prior nonrandomized series and the RTOG 0631 landmark work support single-fraction SSRS (16 Gy) and some retrospective data suggest higher doses may increase local control, but randomized data comparing 16 Gy versus 20 Gy are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.