The Effect of Radiotherapy After Separation Surgery for Spinal Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWei Xu
About this trial
The aim of this clinical study is to explore the impact of whether radiotherapy is administered after spinal metastasis surgery on the prognosis and survival of patients, to describe the clinical outcomes, and to optimize future clinical decisions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years old, gender not limited;
The patient has undergone separation surgery within 3 weeks;
The pathological result of the separation surgery site of the patient indicates that the lesion is a metastatic tumor, and the primary lesion is located outside the spine;
The expected survival period is ≥ 6 months;
Disqualifiers
Patients with poor general condition and those who are intolerant to radiotherapy, chemotherapy, and targeted therapy;
Patients whose treatment segments have not received any other surgical treatment or radiotherapy;
Patients who participated in other clinical trials of drugs or medical devices within 3 months before enrollment;
Other situations judged by the investigator as making the subject unsuitable for enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
radiotherapy
RadiationThe patients receive radiotherapy after the separation surgery.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: No Radiotherapy ArmNo intervention 0 interventions
Group B: Postoperative Radiotherapy Arm.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Time from the date of surgery to the first documented disease progression or death from any cause, whichever occurs first.
Time frame
Baseline up to 24 months.Secondary outcomes
1
Overall Survival（OS）
From the date of surgery until the date of death from any cause.
Time frame
Baseline up to 24 months.2
Pain Assessment
Visual Analogue Scale (VAS)
Time frame
One day before the operation, within 2 weeks after the operation, 3 months after the operation, 6 months after the operation, 12 months after the operation, 18 months after the operation, and 24 months after the operation.3
Quality of Life Evaluation
EORTC QLQ-C30 V3.0 Scale
Time frame
One day before the operation, within 2 weeks after the operation, 3 months after the operation, 6 months after the operation, 12 months after the operation, 18 months after the operation, and 24 months after the operation.4
Complications
All related complications after the surgery.
Time frame
Baseline up to 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wei Xu
Lead sponsor
Shanghai Changzheng Hospital
Sponsor institution
Source ClinicalTrials.gov