The Clinical Efficacy of CT-Guided All-in-One Adaptive Emergency Radiotherapy for Spinal Cord Com… (NCT06608108) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Clinical Efficacy of CT-Guided All-in-One Adaptive Emergency Radiotherapy for Spinal Cord Compression Caused by Spinal Metastases
50 participantsStarted 2025-03-01
Plain-language summary
The aim of this study is to implement a new protocol for concurrent and sequential dose-escalation radiotherapy based on CT-guided all-in-one adaptive emergency radiotherapy for spinal cord compression due to spinal metastases (MSCC). This protocol is designed to assess the clinical efficacy in MSCC patients, with the goals of improving local control rates, functional relief, and optimizing treatment outcomes and safety. The study also seeks to provide reliable data and guidance for future radiotherapy protocol design and clinical practice. Additionally, the study records and analyzes the treatment time required for the all-in-one emergency radiotherapy, aiding in the evaluation of its operational efficiency and clinical feasibility, and providing data support for its broader adoption and dissemination.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1)Diagnosed with MSCC due to spinal metastases confirmed by imaging (MRI or CT).
(2)Acute or subacute onset of MSCC. (3)Modified Tokuhashi score for spinal metastases ≥ 9, indicating an expected survival time \> 6 months.
(4)Spinal instability neoplastic score (SINS) ≤ 7, indicating spinal stability. (5)General performance status (Karnofsky score) ≥ 60. (6)No prior radiotherapy or surgical treatment for the spinal metastases before enrollment.
(7)Patient refuses or is intolerant to surgery. (8)No other severe comorbidities, such as uncontrolled infections or serious cardiopulmonary diseases, that may affect radiotherapy outcomes or increase treatment risks.
(9)No other active malignancies (except for the primary tumor and spinal metastases) to ensure the study's focus.
(10)Age 18 years or older. (11)Informed consent obtained from the patient. (12) Accept CT guided spinal cord compression all in one adaptive emergency radiotherapy for spinal metastases.
Exclusion Criteria:
\- (1)History of radiotherapy or surgery in the affected spinal region leading to MSCC.
(2)Intolerance to radiotherapy. (3)Severe psychiatric or neurological disorders. (4)Pregnant or breastfeeding women. (5)Clear indications that the affected spinal cord region requires decompression surgery first.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local control rate
Timeframe: The time frame extends from the initiation of radiotherapy until the first recorded local recurrence, with an initial assessment period of 24 months.