Predictors of quality of life improvement after surgery for metastatic tumors of the spine: prospective cohort study.
Ori Barzilai, Lily McLaughlin, Mary-Kate Amato...
https://pubmed.ncbi.nlm.nih.gov/29122701/Actively Recruiting
Led by Shanghai Changzheng Hospital · Updated on 2023-11-13
182
Participants Needed
1
Research Sites
104 weeks
Total Duration
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
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
J
Jianru Xiao, Doctor
W
Wei Xu, Doctor
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Shanghai Changzheng Hospital
Lead Sponsor
Peking University Third Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
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
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
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Lead Sponsor
Peking University Third Hospital
Collaborating Sponsor