Status:
RECRUITING
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
Lead Sponsor:
Shanghai Changzheng Hospital
Collaborating Sponsors:
Peking University Third Hospital
Peking University People's Hospital
Conditions:
Spinal Metastases
Spinal Tumor
Eligibility:
All Genders
18-75 years
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 oligometasta...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06120426
Start Date
July 1 2023
End Date
July 1 2027
Last Update
November 13 2023
Active Locations (1)
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1
Shanghai Changzheng hospital
Shanghai, Shanghai Municipality, China, 200003