RecruitingNCT06120426

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

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.

Sponsor

Shanghai Changzheng Hospital

Enrollment

182 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

Surgery Radiotherapy Spinal Metastases Spinal Tumor Malignant Bone Tumor

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

\) Be able to sign written informed consent.
\) Age range from 18 to 75 years old, regardless of gender.
\) 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.
\) 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.
\) Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis.
\) The expected survival period is ≥ 6 months.
No other surgical contraindications

Exclusion Criteria8

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

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Interventions

PROCEDUREtotal en bloc spondylectomy

Total enbloc resection (TES) is one of the most challenging surgeries in spinal surgery and a classic surgical method. It not only relieve spinal cord compression and delays tumor recurrence, but also prolongs patient survival, significantly reduces hand surgery trauma, and improves surgical safety. However, for cases with extensive tumor invasion, methods such as separation surgery should be used to relieve spinal cord nerve compression, rebuild spinal stability, and provide conditions for postoperative radiotherapy.