Neoplasms

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Nervous System Diseases

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Spinal Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Patients undergo posterior spinal tumor resection on day 0.

Patients undergo anterior and posterior tumor resection on day 0.

therapeutic conventional surgery

Undergo anterior and posterior spinal tumor resection

quality-of-life assessment

Rahul Jandial, MD

This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery

PRIMARY OBJECTIVES:

I. Length of operation (operating room \[OR\] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.

SECONDARY OBJECTIVES:

I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function. III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo posterior spinal tumor resection on day 0.

ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.

After completion of study treatment, patients are followed up for 6 months.

Minimally Invasive Surgery in Treating Patients With Spinal Tumors

Comparison of Minimally Invasive Approaches of Spine Tumor Surgery

Will be comparing means with the Wilcoxon test.

This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale

Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artificial induction of joint ossification between two bones via surgery. This is done to relieve intractable pain in a joint which cannot be managed by pain medication.

National Cancer Institute (NCI)

City of Hope Medical Center

Stereotactic body radiotherapy using TomoTherapy

Stereotactic body radiotherapy

Li Zhang, MD

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.

In this observational single-arm study, a total of 45 patients with metastatic spinal tumors will be enrolled. The patients were aged between 18 and 75 years old. And all the subjects should meet the inclusion criteria and sign the informed consent. Meanwhile, the patients' medical history characteristics, including gender, age, imaging data (X-ray, CT, MRI, or PET-CT, etc.), primary tumor type, pathological type, previous treatment, previous disease history, tumor markers and bone metabolism indexes were collected and recorded on the CRF. The metastatic spinal tumors by stereotactic radiotherapy(SBRT) using TomoTherapy. The adiotherapy dose is 6Gy×5Fx, 5Gy×5Fx or 4Gy×5Fx according to the irradiation site. Treatment should be interrupted if there is severe bone marrow suppression, vertebral compression fracture, or radiation myelitis. The adjacentnormal tissue constrains refer to the UK SABR Consortium Guidelines (2022 version). Follow-up was performed 1 month after radiotherapy, thereafter every 3 months for 1-4 years. The parameters includ blood routine, liver and kidney function, bleeding and coagulation function, bone metabolism index, tumor markers, bone metastasis imaging examination. Tumor response will refer to the Cancer Response Criteria and Bone Metastases: RECIST 1.1, MDA and PERCIST.

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

A Clinical Trial of Stereotactic Radiotherapy on Spinal Metastasis

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.

year overall survival (OS): From day of radiotherapy until the date of death or the end in 1 year, 2-year OS: From day of radiotherapy until the date of death or the end in 2 years

1-year Progression-Free Survival (PFS)：From day of radiotherapy until the Progression of bone metastases sites in 1 year, 2-year PFS：From day of radiotherapy until the Progression of bone metastases sites in 2 years

Assessment of pain will be according to the Numerical Rating Scale (NRS).

Bone metastasis-related events will be recorded, including pathological fracture and spinal cord compression, etc.

Epidural spinal cord compression (ESCC) grade will be assessed refer to ESCC scale.

1-Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Minimally Invasive Surgery in Treating Patients With Spinal Tumors	NCT01308489	Adult Spinal Co... Recurrent Adult... Spinal Bone Met... Spinal Cord Met...	therapeutic con... therapeutic con... quality-of-life...	18 Years -	City of Hope Medical Center
A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy	NCT05808998	Spinal Bone Met... Radiation Thera...	Stereotactic bo...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Minimally Invasive Surgery in Treating Patients With Spinal Tumors	NCT01308489	Adult Spinal Co... Recurrent Adult... Spinal Bone Met... Spinal Cord Met...	therapeutic con... therapeutic con... quality-of-life...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for spinal bone metastases