Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors

NCT06587022 | Recruiting

• 1 other identifier: ST-SBRT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors.

Conditions

Spinal Tumor

Outcome Measures

Primary Outcomes (2)

• Disease Control Rate（DCR）

  Disease Control Rate（DCR），including complete response（CR），partial response(PR) and stable disease(SD ).

  2 years

• Pain relief rate

  VAS Score(Visual Analog Scale Score) decreased after treatment

  3 months

Secondary Outcomes (1)

• Incidence of side effects

  2 years

Study Arms (2)

group 1

Group 1(small target delineation)：The target bolume only includes local tumor.

Radiation: Target volume delineation

group 2

Group 2(small target delineation)：The target bolume includes local tumor and adjacent vertebral area.

Radiation: Target volume delineation

Interventions

Target volume delineation RADIATION

Group 1(small target delineation)：The target bolume only includes local tumor. Group 2(small target delineation)：The target bolume includes local tumor and adjacent vertebral area.

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant tumor spinal metastasis who received or will receive stereotactic radiotherapy, without preoperation.

You may qualify if:

• Patients with spinal metastases or primary tumors receiving stereotactic radiotherapy;
• Patients with sufficent pre-treatment imaging data
• Patients who can cooperate with imaging review and follow-up after radiotherapy.

You may not qualify if:

• Patients with an expected survival of less than 3 months;
• Patients with second-course radiotherapy;
• Patients with physical conditions that cannot tolerate stereotactic radiotherapy;
• Patients with extensive spinal metastasis and no local therapeutic value

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hongqing Zhuang

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Hongqing Zhuang, Doctor

CONTACT

13051776232; hongqingzhuang@163.com

Yuxia Wang

CONTACT

15001292991; lily31415926@126.com

Study Design

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

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2017
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)