Trial Title:
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
NCT ID:
NCT06120426
Condition:
Spinal Metastases
Spinal Tumor
Radiotherapy
Malignant Bone Tumor
Surgery
Conditions: Official terms:
Neoplasms
Bone Neoplasms
Spinal Cord Neoplasms
Spinal Neoplasms
Conditions: Keywords:
Total enbloc spondylectomy
Oligometastases
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
total en bloc spondylectomy
Description:
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.
Arm group label:
Total en bloc spondylectomy for spinal oligometastases
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
Criteria for eligibility:
Study pop:
According to the literature results, the median survival period of the experimental group
was 20 months, while the median survival period of the control group was 11 months. The
total study duration (enrollment+follow-up) was 48 months, and the enrollment time
(assuming uniform enrollment speed) was 24 months. The bilateral alpha was 0.05, the beta
was 0.2, and the ratio of sample size between the two groups was 2 (experimental group:
control group). Through the difference test of median survival time, the experimental
sample size was calculated: 110 cases in the experimental group, 55 cases in the control
group, a total of 165 cases, Considering 10% detachment, a total of 182 samples are
required.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Shanghai Changzheng hospital
Address:
City:
Shanghai
Zip:
200003
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianru Xiao, Doctor
Phone:
13701785283
Email:
jianruxiao83@163.com
Contact backup:
Last name:
Wei Xu, Doctor
Phone:
13761278657
Email:
xuweichangzheng@hotmail.com
Start date:
July 1, 2023
Completion date:
July 1, 2027
Lead sponsor:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Tianjin Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Nanchang University
Agency class:
Other
Collaborator:
Agency:
The Third Affiliated Hospital of Southern Medical University
Agency class:
Other
Source:
Shanghai Changzheng Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120426
