Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors

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Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06587022
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking University Third Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hongqing Zhuang
Principal Investigator Affiliation	Peking University Third Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Tumor

Additional Details

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.

Arms & Interventions

Arms

: group 1

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

: group 2

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

Interventions

Radiation: - Target volume delineation

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.

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