A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy

NCT05808998 | Unknown

• 1 other identifier: ZS-SM-SBRT
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single-center observational clinical trial will be performed for metastatic spinal tumors by stereotactic radiotherapy using TomoTherapy. In this study, we will explore the local control rate (LCR), disease-free progression time (PFS), overall survival time (OS), and pain relief in patients with spinal metastasis, so as to provide a basis for developing relevant guidelines or consensus.

Conditions

Spinal Bone Metastases; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 1-year local control rate

  The proportion of complete remission, partial remission, stable disease, and disease progression patients in the total number of enrolled cases. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.

  2024.4-2025.4

Secondary Outcomes (6)

• 1- and 2- year overall survival (OS)

  2024.4-2026.4

• 1- and 2-year Progression-Free Survival(PFS)

  2024.4-2026.4

• Pain relief

  2024.4-2026.4

• Bone metastasis-related events (SRE)

  2024.4-2026.4

• Epidural spinal cord compression (ESCC) grade

  2024.4-2026.4

Interventions

Stereotactic body radiotherapy RADIATION

Stereotactic body radiotherapy using TomoTherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 45 patients with spinal metastases were enrolled in this study.

You may qualify if:

• Spinal metastasis diagnosed by emission computed tomography, X-ray examination, computed tomography, magnetic resonance imaging (MRI) or 18F-fluorodeoxy glucose positron emission tomography within 6 weeks before enrollment;
• Patients with unresectable spinal metastases;
• SBRT was for patients with painful spinal metastases, physiological hypofunction, decreased behavioral capacity and quality of life. And SBRT was used to help to prevent or delay skeletal related event (SRE). Including postoperative radiotherapy (especially post-separation), single or salvage radiotherapy;
• age 18-75 years old;
• KPS score equal to 70 points or over;
• Patients were required to have histologically confirmed metastatic disease from solid tumors, such as breast cancer, renal carcinoma or liver cancer;
• The distance between metastatic lesion and spinal cord was more than 3mm；
• Hemoglobin \>90g/L, white cells count≥3.5×109/L, platelet count≥80×109/L, within 1 week before treatment;
• No birth plans for the duration of study participation and up to 3 months following completion of therapy;
• Sign the informed consent.

You may not qualify if:

• Spinal cord or cauda equina compression, the rapid decrement of neurological function or paralysis;
• A compression fracture of the spine, spinal instability and subsequent inability to lie on back;
• Metastatic lesions more than 5cm;
• Multilevel segments involvement, including more than 5 metastatic segments, or 3 isolated lesions, or exceed two adjacent vertebrae;
• The treatment site had received prior radiotherapy prior to the initiation of the study;
• Complicated with other malignant tumors or severe internal diseases affected the prognosis;
• Cannot tolerate radiation therapy, including the ones with scleroderma or connective tissue diseases, or cann't complete the radiation treatment according to the research;
• Pregnant women or breast feeding mothers;
• Systemic radionuclide therapy within 30 days before SBRT, or external radiotherapy within 90 days before SBRT;
• Pathologically confirmed as myeloma or lymphoma.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Li Zhang, MD

CONTACT

17821701209; zhang.li12@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: April 12, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-03