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 range18 Years – 80 Years
SexALL
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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.
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.