Standard Dose Versus High Dose Stereotactic Spine Radiosurgery for Metastatic Spinal Neoplasms - SHINE: A Prospective Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 4
- 主要终点
- Rate of Composite Treatment Failure at 12 Months
研究概览
简要总结
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.
详细描述
Study Rationale and Background:
Metastatic cancer to the spine is a significant clinical challenge that can lead to severe pain, neurological compromise, and a diminished quality of life. Stereotactic Spine Radiosurgery (SSRS), also known as Stereotactic Ablative Radiotherapy (SABR), has emerged as a paradigm-shifting treatment. This advanced, non-invasive technique allows for the delivery of a single, highly ablative dose of radiation with unprecedented precision, which has shown excellent rates of pain control and tumor response while minimizing dose to the adjacent, critical spinal cord.
Despite the widespread adoption and promising results of SSRS, the optimal dose-fractionation schedule remains an area of active investigation. Previous research, including the landmark RTOG 0631 trial, has established single-fraction 16 Gy as an effective regimen. However, other evidence suggests that a higher radiation dose may lead to more durable local tumor control. This prospective, randomized phase II study, known as the SHINE trial, is designed to formally compare the efficacy and safety of a higher single-fraction dose against the current standard dose.
Study Design and Procedures:
This is a two-arm, parallel-group, randomized, open-label, multi-center study. After providing informed consent and confirming eligibility, participants will be randomly assigned on a 1:1 basis to receive either the standard dose or the high dose of SSRS. The randomization process will incorporate a minimization procedure to ensure balance between the two arms for the key prognostic factor of epidural or paraspinal tumor extension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
- •Pregnant or breast-feeding women
结局指标
主要结局
Rate of Composite Treatment Failure at 12 Months
时间窗: At 12 months after the single fraction of Spine Stereotactic Radiosurgery (SSRS).
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.
次要结局
- 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.)