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

Launched by SHANGHAI CHANGZHENG HOSPITAL · Nov 2, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two different surgical approaches for patients with spinal oligometastatic cancer, which is a type of cancer that has spread to the spine from other parts of the body but is still limited in number. The two methods being compared are En bloc resection, where the tumor and surrounding tissue are removed all at once, and separation surgery combined with radiation therapy. The goal is to see which approach offers better outcomes in terms of patient survival and overall health.

To be eligible for this trial, participants need to be between 18 and 75 years old, able to provide informed consent, and have specific symptoms or medical imaging results indicating spinal metastases. They should not have more than three metastatic organs or five metastatic lesions in their body, and they should expect to live for at least six more months. If you participate, you will receive one of the two treatment methods and be monitored for your health outcomes. This study is currently recruiting participants, so if you or someone you know fits the criteria and is looking for treatment options, this could be a valuable opportunity to consider.

Gender

ALL

Eligibility criteria

• 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.