Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338Actively Recruiting
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID06120426
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor - A Multi-center, Prospective, Randomized, Controlled Study
Led by Shanghai Changzheng Hospital · Updated on 2023-11-13
182
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
P
Peking University Third Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore how two types of surgeries combined with radiation therapy affect prognosis and survival in patients with spinal oligometastatic cancer. Patients with fewer metastatic sites often have better outcomes, and aggressive local treatments like surgery and targeted radiotherapy may improve survival. The study seeks to clarify the impact of these treatments on clinical outcomes and guide future care for spinal oligometastatic tumors. The trial compares two approaches: total en bloc spondylectomy, a complex surgery that removes the tumor and aims to relieve spinal compression and delay recurrence, and separation surgery followed by radiotherapy after recovery. Both treatments are for patients diagnosed with spinal oligometastases. Researchers will observe clinical results to understand the benefits and optimize treatment goals. Participants will undergo surgical procedures and follow-up assessments including imaging scans, pain inventories, quality of life questionnaires, and monitoring for complications at multiple time points up to one year after surgery. The main outcome measured is overall survival from surgery until death related to the primary disease. Additional outcomes include local tumor control, progression-free survival, pain levels, quality of life, and complication rates. The study will help evaluate the effects of these treatments on patient prognosis and quality of care over time.
CONDITIONS
Brief Title
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
Who Can Participate
Age: 18Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Able to sign written informed consent
- Age between 18 and 75 years, any gender
- Have uncontrollable pain, progressing metastatic lesions, spinal instability, or spinal cord/nerve compression symptoms despite conservative treatment
- PET-CT showing no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body, with at least 1 and at most 5 spinal metastases
- Imaging (enhanced MRI, CT, X-ray) confirming spinal metastasis
- Expected survival of 6 months or longer
- No surgical contraindications
You will not qualify if you...
- Primary spinal tumors or multiple tumors with more than 3 metastatic organs and more than 5 metastatic sites
- Previous spinal surgery or radiotherapy to the responsible segment
- Severe heart, lung, liver, kidney, or other diseases affecting surgery
- Cognitive impairment or inability to understand basic instructions
- Participation in other drug or device clinical trials within 3 months prior
- Infectious diseases
- Refusal to follow up or participate
- Determined unsuitable for enrollment by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Surgery and Immediate Post-operative Care
Duration - Hospital stay duration as per surgical recovery
Participants undergo either total en bloc spondylectomy or separation surgery to treat spinal oligometastatic tumors, followed by immediate recovery.
1 surgical hospital stay
Post-operative Follow-up
Duration - 12 months post surgery
Participants are monitored for pain, quality of life, and complications after surgery with regular assessments.
Visits at 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery
Radiotherapy (for separation surgery group only)
Duration - Duration of radiotherapy as per clinical plan
Participants who had separation surgery receive radiotherapy after surgical recovery to target spinal tumors.
Visit schedule varies depending on radiotherapy treatment
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
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Research Team
J
Jianru Xiao, Doctor
W
Wei Xu, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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