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NCT Number: NCT06587022

Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Hongqing Zhuang

CONTACT

[email protected]

13051776232

About this study

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. This is a bidirectional cohort study planned to enroll approximately 500 patients with metastatic spinal tumors. Patients are divided into two groups according to the target delineation method. Group 1:The target bolume only includes local tumor. Group 2:The target bolume includes local tumor and adjacent vertebral area.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Disease Control Rate(DCR)

    Time frame: 2 years

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

  2. Pain relief rate

    Time frame: 3 months

    VAS Score(Visual Analog Scale Score) decreased after treatment

Secondary outcomes

  1. Incidence of side effects

    Time frame: 2 years

    radiation myelitis,radiation esophagitis, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongqing Zhuang, Doctor

CONTACT

[email protected]

13051776232

Yuxia Wang

CONTACT

[email protected]

15001292991

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Acronym: ST-SBRT

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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