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Clinical study on the efficacy and safety of intraoperative radiotherapy in the spinal metastases

Clinical study on the efficacy and safety of intraoperative radiotherapy in the spinal metastases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014439
Enrollment
Unknown
Registered
2018-01-13
Start date
2018-02-01
Completion date
Unknown
Last updated
2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal metastases

Interventions

OP group:Surgery only

Sponsors

Sun-Yat-Sen Memorial Hospital, Sun-Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) over 18 years old; 2) the history of malignant tumor and / or imaging / pathology were diagnosed as spinal metastases; 3) involvement of the vertebral body was T3-T12, L1-L5; 4) expected survival time more than 3 months; 5) VAS pain score =3, or pathological fracture of vertebral body, spinal cord compression and metastases.

Exclusion criteria

Exclusion criteria: 1) intolerance of anesthesia and prone position; 2) patients with coagulation disorders; 3) patients who were unable to perform MRI/CT examination; 4) pregnant / lactation women; 5) mental illness that cannot be informed of informed consent; 6) other serious diseases that may lead to shorter survival and chronic pain; 7) dyscrasia, organ function decompensation; 8) drug abuse and medical, psychological or social conditions may interfere with the patient's participation in the study or the assessment of the results of the study; 9) any allergy to the study of drug allergy or any drug allergy to this test is known or suspected; 10) any unstable state or condition that may jeopardize the safety and compliance of the patient.

Design outcomes

Primary

MeasureTime frame
Local control rate;Pain;

Secondary

MeasureTime frame
Spinal stability;Neurologic function;Activity ability;Surgery complication;Radiation complication;Life period;

Countries

China

Contacts

Public ContactKeng Chen

Sun-Yat-Sen Memorial Hospital, Sun-Yat-Sen University

chen.keng@qq.com+86 13602425774

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026