An observational study in Spinal Metastases, Spinal Tumor and Radiotherapy, sponsored by Shanghai Changzheng Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Shanghai Changzheng Hospital · Observational
Among 14 studies in Spinal Cord Neoplasms with a site in China — 7 open to participants now, 7 under way, none of them phase 3. Spinal Cord Neoplasms · China.
Among the 14 studies in Spinal Cord Neoplasms with a site in China, this one is one of 2 that started in 2023, is one of 8 observational ones, and was the 10th registered.
105 studies on the registry are indexed under Spinal Cord Neoplasms; 27 are open to participants now.
Browse Spinal Cord Neoplasms studies →7 of the 14 studies in Spinal Cord Neoplasms with a site in China are open now. Recruiting first, the newest first:
Wei Xu · Sites in China
Ages 18+
Shengjing Hospital · Sites in China
Ages 18–80 · Healthy volunteers
Beijing Tiantan Hospital · Sites in China
Ages 3–75
Peking University Third Hospital · Sites in China
Ages 18–90
Beijing Tsinghua Chang Gung Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 23 Spinal Cord Neoplasms studies recruiting now, 15 (65%) set no upper age limit and 5 (22%) stop at 75 or younger; 6 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 182 is above the median of 150 across 31 observational studies indexed under Spinal Cord Neoplasms.
Median enrollment 103 across the 6 interventional studies, 125 across the 8 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 14 have an industry lead sponsor. The 10 most frequent:
Shanghai Changzheng Hospital is the lead sponsor of 128 studies on the registry; 60 are open to participants now.
Shanghai Changzheng Hospital has 2 studies filed under Spinal Cord Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies in Spinal Cord Neoplasms with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06587022Peking University Third HospitalDelineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors | 2026-12-30 |
| NCT07066475Beijing Tiantan HospitalA Registry-Based Cohort Study on the Clinical Outcomes of Spinal Cord Glioma Resection Via the Dorsolateral Sulcus Approach | 2026-12-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 14 studies in Spinal Cord Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Based on the medical history, physical signs, and imaging examination results, a definitely diagnosis of spinal oligometastasis tumor was made and perform a Total en bloc spondylectomy.
Procedure: total en bloc spondylectomy
Based on the medical history, physical signs, and imaging examination results, a definitely diagnosis of spinal oligometastasis tumor was made and perform a Separation surgery. After surgical recovery, take a radiotherapy.
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.
Overall Survival(OS)
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: after surgery until death due to primary disease or responsible segment
Local Control Rate(LRC)
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: 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.
Progression-Free Survival(PFS)
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: The period between the patient receiving this treatment and observing local progression or death from any cause.
Brief Pain inventory
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.
EORTC Quality of Life Questionnaire - Core 30
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 day before surgery, 2 weeks after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery, and 12 months after surgery
Complication
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.
Time frame: 1 month, 3 months, 6 months, and 12 months after surgery.
Started Jul 2023 (actual). Primary completion is estimated for Jul 2025, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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Shanghai Changzheng Hospital →