En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

Recruiting

• Conditions: Radiotherapy; Spinal Metastases; Spinal Tumor; Malignant Bone Tumor; Surgery
• Interventions: Procedure: total en bloc spondylectomy

• Registration Number: NCT06120426
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

Detailed Description

Patients with oligometastatic diseases have been shown to have better prognosis than those with multiple metastatic diseases, and some patients have achieved long-term survival, thus being considered to benefit from more aggressive treatment. Active local treatment, including surgery and/or targeted radiotherapy, such as Stereotactic Radiosurgery (SRS) and Stereotactic body radiotherapy (SBRT), can be performed before or after systemic treatment. For both primary and oligometastatic tumors, radical treatment should be considered in order to achieve better survival and prognosis. The current research has explored the different effects of oligometastatic disease status on the prognosis of various cancers. However, there is currently no clear clinical or experimental confirmation of the impact on the survival and treatment outcomes of patients with oligometastatic spinal cancer. The purpose of this clinical trial is to explore the impact of En bloc hand surgery and separation surgery combined with radiotherapy on the prognosis and survival of patients with oligometastatic spinal cancer, Describe clinical outcomes and optimize future treatment goals

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• 1. Be able to sign written informed consent.
• 2. Age range from 18 to 75 years old, regardless of gender.
• 3. Within conservative treatment, the patient still has uncontrollable pain, metastatic cancer lesions that still progress, spinal instability/potential instability, or symptoms of spinal cord/nerve compression.
• 4. After the patient underwent Positron Emission Tomography-Computed Tomography (PET-CT) examination, it was indicated that there were no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body of cancer. Among them, there was at least 1 spinal metastasis and at most 5 spinal metastases.
• 5. Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis.
• 6. The expected survival period is ≥ 6 months.
• 7)No other surgical contraindications

Exclusion Criteria

• 1. Primary tumors of the spine or multiple tumors of the body, with>3 metastatic organs and>5 metastatic sites.
• 2. Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment.
• 3. Severe heart, lung, liver, kidney or other diseases affecting the surgery.
• 4. Having cognitive impairment, sensory aphasia, and inability to understand basic instructions.
• 5. Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment.
• 6. Infectious diseases.
• 7. Refuse to follow up or participate.
• 8. The researchers determine that the patients are not suitable for enrollment this clinical trail.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total en bloc spondylectomy for spinal oligometastases	total en bloc spondylectomy	Based on the medical history, physical signs, and imaging examination results, a definitely diagnosis of spinal oligometastasis tumor was made and perform a Total en bloc spondylectomy.

Primary Outcome Measures

Name	Time	Method
Overall Survival(OS)	after surgery until death due to primary disease or responsible segment	On the basis of maintaining systemic treatment, compare the overall survival period of En bloc surgery and separation surgery combined with radiation therapy for patients with spinal oligometastatic cancer, after surgery until death due to primary disease or responsible segment.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival(PFS)	The period between the patient receiving this treatment and observing local progression or death from any cause.	The period between the patient receiving this treatment and observing local progression or death from any cause. Based on the changes in patient imaging and neurological function, comprehensively evaluate whether the local lesion of the spine is progressing.
Brief Pain inventory	1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.	Use the Brief Pain Inventory (BPI) to score the pain levels 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.
Complication	1 month, 3 months, 6 months, and 12 months after surgery.	The incidence of vertebral compression fractures: X-ray examination of the surgical area was performed on the first day, within 3 months, within 6 months, and within 12 months respectively.; Wound complications: Erythrocyte Sedimentation Rate (ESR) and C-reactive protein tests were performed on the first day after surgery. Observe and record the incidence of incision infection, incision non healing, and the need for debridement within 1 month after surgery.; Other complications: Observe whether the patient experiences bleeding, pulmonary infection, or pulmonary embolism within one month after treatment.
Local Control Rate(LRC)	a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline.	Based on the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), it is defined as a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline.
EORTC Quality of Life Questionnaire - Core 30	1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery	Evaluate the quality of life of patients 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery using EORTC Quality of Life Questionnaire - Core 30

Trial Locations

Locations (1)

Shanghai Changzheng hospital; 🇨🇳 Shanghai, Shanghai, China