The Clinical Efficacy of CT-Guided All-in-One Adaptive Emergency Radiotherapy for Spinal Cord Compression Caused by Spinal Metastases

NCT06608108 | Not Yet Recruiting

• 1 other identifier: 551-02
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malignant Spinal Cord Compression

Outcome Measures

Primary Outcomes (1)

• Local control rate

  The time frame extends from the initiation of radiotherapy until the first recorded local recurrence, with an initial assessment period of 24 months. Patients will be followed up one month and three months after treatment, and subsequently every three months.

  The time frame extends from the initiation of radiotherapy until the first recorded local recurrence, with an initial assessment period of 24 months.

Secondary Outcomes (3)

• Neurological function assessment

  An assessment will be conducted after each radiotherapy session. Patients will be followed up one month and three months after treatment, and subsequently every three months. The initial time frame is 24 months.

• Pain evaluation

  An assessment will be conducted after each radiotherapy session. Patients will be followed up one month and three months after treatment, and subsequently every three months. The initial time frame is 24 months.

• Emergency radiotherapy treatment time

  1 day (Record the duration of each emergency radiotherapy session. The time frame is the period during which the All-in-One emergency radiotherapy is administered.)

Study Arms (1)

Group 1

Non-interventional studies

Other: Non-intervention

Interventions

Non-intervention OTHER

Non-intervention

Group 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the inclusion and exclusion criteria, 50 patients were included.

You may qualify if:

• (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.

You may not qualify if:

• \- (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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Central Study Contacts

Junjie Wang professor

CONTACT

0086-17355240686; junjiewang@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 23, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share