Shanghai Changzheng hospital
Shanghai, Shanghai Municipality, 200003, China
Location status: Recruiting
Location contact
Jianru Xiao, Doctor
CONTACT
Wei Xu, Doctor
CONTACT
NCT Number: NCT06120426
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
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200003, China
Location status: Recruiting
Jianru Xiao, Doctor
CONTACT
Wei Xu, Doctor
CONTACT
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: after surgery until death due to primary disease or responsible segment
On the basis of maintaining systemic treatment, compare the overall survival period of En bloc surgery and separation surgery combined with radiation therapy for patients with spinal oligometastatic cancer, after surgery until death due to primary disease or responsible segment.
Time frame: a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline.
Based on the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), it is defined as a 20% increase in the total diameter of the target lesion observed on imaging from the beginning of the patient's current treatment to baseline.
Time frame: The period between the patient receiving this treatment and observing local progression or death from any cause.
The period between the patient receiving this treatment and observing local progression or death from any cause. Based on the changes in patient imaging and neurological function, comprehensively evaluate whether the local lesion of the spine is progressing.
Time frame: 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.
Use the Brief Pain Inventory (BPI) to score the pain levels 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery.
Time frame: 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery
Evaluate the quality of life of patients 1 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery using EORTC Quality of Life Questionnaire - Core 30
Time frame: 1 month, 3 months, 6 months, and 12 months after surgery.
The incidence of vertebral compression fractures: X-ray examination of the surgical area was performed on the first day, within 3 months, within 6 months, and within 12 months respectively.
Wound complications: Erythrocyte Sedimentation Rate (ESR) and C-reactive protein tests were performed on the first day after surgery. Observe and record the incidence of incision infection, incision non healing, and the need for debridement within 1 month after surgery.
Other complications: Observe whether the patient experiences bleeding, pulmonary infection, or pulmonary embolism within one month after treatment.
Contact information is provided by the study sponsor or research team.
Jianru Xiao, Doctor
CONTACT
Wei Xu, Doctor
CONTACT
Shanghai Changzheng Hospital
Other
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor-A Multi-center, Prospective, Randomized, Controlled Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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