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

NCT07039968 | Recruiting Phase 2

• 1 other identifier: 202503019RINA
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Neoplasms

Keywords

spine metastasis; stereotactic spine radiosurgery

Outcome Measures

Primary Outcomes (1)

• Rate of Composite Treatment Failure at 12 Months

  This is a composite endpoint that measures the percentage of participants in each arm who experience a treatment failure. A treatment failure is defined as the first occurrence of either of the following events: Clinically Significant Toxicity: The occurrence of a Grade 3 or higher adverse event that is definitely, probably, or possibly related to the radiation treatment. This includes specific neurological, musculoskeletal (e.g., spinal fracture), or gastrointestinal events as defined in the protocol. Local Tumor Progression: Unequivocal evidence of tumor growth at the treated spinal site, which is significant enough to warrant further medical intervention, such as spinal surgery or re-irradiation.

  At 12 months after the single fraction of Spine Stereotactic Radiosurgery (SSRS).

Secondary Outcomes (1)

• Health-Related Quality of Life (EORTC QLQ-C15-PAL)

  Baseline, and at 1, 3, 6, 9, and 12 months post-treatment, and then every 3 months for a total follow-up period of up to 24 months.

Study Arms (2)

Standard Dose Spine Stereotactic Radiosurgery

ACTIVE COMPARATOR

Participants randomized to this arm will receive Spine Stereotactic Radiosurgery (SSRS) delivered at a dose of 16 Gray (Gy) in a single treatment session.

Radiation: Spine Stereotactic Radiosurgery (SSRS)

High Dose Spine Stereotactic Radiosurgery

EXPERIMENTAL

Participants randomized to this arm will receive Spine Stereotactic Radiosurgery (SSRS) delivered at a higher dose of 20 Gray (Gy) in a single treatment session.

Radiation: Spine Stereotactic Radiosurgery (SSRS)

Interventions

Spine Stereotactic Radiosurgery (SSRS) RADIATION

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.

High Dose Spine Stereotactic Radiosurgery; Standard Dose Spine Stereotactic Radiosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify 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 significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
• 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
• Pregnant or breast-feeding women

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital Hsin-Chu Branch: collaborator
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• National Taiwan University: collaborator

Study Sites (2)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

National Taiwan University Cancer Center

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Neoplasms

Condition Hierarchy (Ancestors)

Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Central Study Contacts

Feng-Ming Hsu, M.D., Ph.D

CONTACT

886-2-23123456; hsufengming@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 26, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2035
• Study Completion (Estimated): June 1, 2035
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)