Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors

NCT04192383 | Unknown

• 1 other identifier: IRB00006761-M2018251
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the reliability of the combination of functional magnetic resonance imaging and radiomics for evaluation of the therapeutic efficacy of CyberKnife stereotactic radiosurgery for spinal tumors. Accurate imaging assessment can help clinicians plan personalized therapeutic schedules for patients with spinal tumors .

Conditions

Spinal Neoplasms

Keywords

Spinal Neoplasms; Stereotactic Body Radiotherapy; CyberKnife Radiosurgery; Functional MRI; treatment outcome

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  The time from the start of treatment to the date of death or last follow-up

  From the start of randomization to the date of death of the patient or the end of the study (at 60 months).

Secondary Outcomes (3)

• Progression-free survival(PFS)

  From the start of randomization to the first evidence of tumor progression or death of the patient or the end of the study (at 60 months), whichever occurs first.

• Numerical rating scales (NRS)

  Measurements will be performed every 3 months, starting from randomization until the patient's death or till end of the study (at 60 months ).

• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

  Measurements will be performed every 3 months, starting from randomization until the patient's death or till end of the study (at 60 months ).

Study Arms (1)

Cyberknife

Radiation: Cyberknife stereotactic radiosurgery

Interventions

Cyberknife stereotactic radiosurgery RADIATION

Hypofractionated stereotactic radiosurgery

Cyberknife

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohorts will be selected form Peking University Third Hospital.

You may qualify if:

• Biopsy-proven spinal or paraspinal metastases;
• MRI and DCE-MRI examination performed before and at 3 months after CyberKnife treatment.

You may not qualify if:

• Area of the lesion surgically removed before enrollment;
• Prior percutaneous vertebroplasty or kyphoplasty or radiation therapy of the target lesion;
• Chemotherapy within a month;
• Unable to cooperate with-or refusal of-CT, conventional MRI, or DCE-MRI examination;
• Lost to follow-up;
• Poor image quality that cannot be analyzed.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Yongye Chen

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Spinal Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: September 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-02

Locations

CN (1)