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RECRUITING

NCT07039968

PHASE2

Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

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. The main questions it aims to answer are: Does a higher radiation dose lead to fewer treatment failures (meaning the tumor growing back or causing serious side effects) one year after treatment? What are the side effects associated with the high dose compared to the standard dose? How does each radiation dose affect a patient's pain and quality of life? Researchers will randomly assign participants (like a coin toss) to one of two groups to compare the outcomes: The Standard Dose Group: Will receive a single radiation treatment of 16 Gy. The High Dose Group: Will receive a single, more powerful radiation treatment of 20 Gy. Participants in this study will: Receive a single, one-time, highly-focused radiation treatment (SSRS) to the spinal tumor. Attend regular follow-up visits at the clinic for checkups and imaging scans (like MRI). Complete questionnaires about their pain levels and quality of life during these visits.

Official title: Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms - SHINE: A Prospective Randomized Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

196

Start Date

2025-06

Completion Date

2035-06

Last Updated

2025-06-26

Healthy Volunteers

Conditions

Spinal Neoplasms

Interventions

RADIATION

Spine Stereotactic Radiosurgery (SSRS)

A non-invasive procedure that uses highly focused, high-energy radiation beams to precisely target metastatic tumors in the spine. The procedure is delivered using advanced techniques like Intensity Modulated Radiotherapy (IMRT) or Volumetric Modulated Arc Therapy (VMAT/RapidArc), which allow the radiation dose to conform tightly to the shape of the tumor. This approach maximizes the dose to the cancer while carefully sparing surrounding healthy tissues, especially the critical spinal cord. The entire course of treatment is delivered in a single session, guided by on-board imaging to ensure sub-millimeter accuracy.

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

Locations (2)

National Taiwan University Hospital

Taipei, Taiwan

National Taiwan University Cancer Center