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Metastatic Spinal TumorsNCT07527728

Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases

An observational study of Metastatic Spinal Tumors and Spinal Cord Compression, run by Shanghai Changzheng Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Metastatic spinal tumors represent a common and devastating complication in patients with advanced solid malignancies. Up to 40% of cancer patients may develop spinal metastases during the course of their disease, often resulting in intractable pain, neurological deficits, and spinal instability. Read more about this study

Who is it for?
Any age
How many people
150 participants
Where
No sites listed yet
Study dates
1 May 2026to 30 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population includes adult patients (aged 18-80 years) diagnosed with spinal metastases resulting in motor paralysis, who are scheduled to undergo surgical decompression and/or stabilization. All participants must be physically fit for surgery, provide written informed consent, and be able to complete postoperative neurological assessments. Patients with cognitive impairment, pregnancy, or incomplete follow-up data will be excluded.

Who may be able to join

  • Age between 18 and 80 years at the time of enrollment.
  • Clinical diagnosis of spinal metastases with resulting motor paralysis.
  • Scheduled for surgical decompression and/or spinal stabilization.
  • Medically fit to undergo surgery as determined by preoperative evaluation.
  • Ability to understand the study and provide written informed consent.
  • Willingness and ability to complete neurological and functional follow-up assessments.

Who cannot join

  • Medically unfit for surgery due to unstable comorbidities or poor general condition.
  • Pregnant or breastfeeding at the time of enrollment.
  • Significant cognitive impairment or psychiatric illness that interferes with informed consent or study participation.
  • Expected difficulty in completing follow-up assessments or anticipated loss to follow-up.
  • Missing critical baseline or follow-up data relevant to study endpoints.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Metastatic spinal tumors represent a common and devastating complication in patients with advanced solid malignancies. Up to 40% of cancer patients may develop spinal metastases during the course of their disease, often resulting in intractable pain, neurological deficits, and spinal instability. One of the most serious consequences is motor paralysis caused by metastatic epidural spinal cord compression (MESCC), which can severely impair patients' quality of life and limit their ability to receive subsequent anti-tumor therapy. Although surgical decompression and stabilization are recognized as effective strategies for relieving spinal cord compression and restoring spinal integrity, the neurological prognosis for patients who present with paralysis remains uncertain and heterogeneous.

This prospective, single-center, observational cohort study aims to evaluate the early and mid-term neurological recovery trajectories in patients with paralysis caused by spinal metastases, and to identify perioperative clinical factors associated with favorable or poor functional outcomes. The study will be conducted at Shanghai Changzheng Hospital, a tertiary care academic center with extensive experience in spinal oncology and multidisciplinary cancer care.

Read more

The investigators plan to consecutively enroll adult patients (aged 18-80) diagnosed with spinal metastatic tumors who present with motor paralysis and are deemed appropriate surgical candidates by a multidisciplinary tumor board. Participants will undergo surgical decompression and stabilization based on individualized tumor location and spinal instability. The study does not involve any investigational drug or device. All surgical procedures and adjuvant treatments (such as radiotherapy or systemic therapy) will be delivered according to standard of care.

Preoperative evaluations will include spinal imaging (MRI, CT), neurological scoring using the ASIA Impairment Scale, and assessments of systemic condition, spinal instability (SINS), and epidural compression severity (ESCC scale). Participants will be followed at 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery to monitor neurological recovery, pain control, bowel/bladder function, treatment complications, and survival.

The primary outcome is the improvement in motor function at 1 month postoperatively, quantified by changes in ASIA motor scores. Secondary outcomes include longer-term neurological recovery, progression of bowel and bladder function, quality of life, complication rates, disease progression, and survival outcomes. Additional analyses will explore the impact of variables such as timing of surgery, tumor histology, location of compression, and performance status on recovery.

This study will employ both univariate and multivariate statistical methods to identify independent predictors of postoperative neurological improvement, using logistic regression and time-to-event analyses. A total of 150 participants will be recruited, based on power analysis accounting for key covariates and anticipated dropout rates.

Through this prospective clinical registry and analysis, the study aims to provide evidence-based data to guide clinical decision-making in the management of MESCC with paralysis. The findings will help inform surgical indications, optimize timing of intervention, and support the development of prognostic tools for patient counseling. Given the limited life expectancy of many patients with advanced cancer, maximizing early neurological recovery may directly impact patient autonomy, eligibility for systemic therapy, and overall quality of life.

Medical subject headings
Spinal Cord Neoplasms, Spinal Cord Compression, Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07527728
Study groupRoleWhat they receive
Patients with Paralysis Due to Spinal Metastases.Patients with paralysis due to spinal metastases who undergo surgery will be included in this cohort and followed over time to assess clinical outcomes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Achieving Improvement in ASIA Impairment Grade at 1 Month Post-Surgery

    The primary outcome is the distribution and change in ASIA Impairment Grades at 1 month after surgery compared to baseline. The ASIA (American Spinal Injury Association) Impairment Scale categorizes spinal cord injury severity from Grade A (complete injury) to Grade E (normal motor and sensory function). An improvement is defined as a shift to a higher ASIA grade (e.g., from C to D or D to E). The proportion of patients showing at least 1-grade improvement will be calculated to reflect early neurological recovery following surgical decompression and stabilization for metastatic spinal cord compression.

    Measured: Baseline (preoperative) to 1 month postoperatively

Secondary outcomes (22)
  1. Sex of Participant

    Sex (male or female) will be recorded as a baseline demographic variable and may be analyzed for its association with neurological recovery after spinal metastasis surgery.

    Measured: preoperative

  2. Age of Participant

    The patient's age at the time of surgery (in years) will be recorded to assess its relationship with postoperative neurological function and general prognosis.

    Measured: preoperative

  3. ECOG Performance Status

    Preoperative physical condition will be assessed using ASA (American Society of Anesthesiologists) classification and ECOG (Eastern Cooperative Oncology Group) score to explore their potential as predictors of surgical recovery and survival.

    Measured: preoperative

  4. Time from Primary Cancer Diagnosis to Surgery

    The interval (in months) from the initial diagnosis of the primary malignancy to the time of spinal surgery will be recorded to evaluate potential prognostic implications.

    Measured: preoperative

  5. Time from Spinal Metastasis Diagnosis to Surgery

    The time between the diagnosis of spinal metastasis and the surgical intervention will be measured in months to assess whether earlier surgical timing influences neurological outcomes.

    Measured: preoperative

  6. Histological Type of Primary Tumor

    Primary tumor pathology (e.g., lung adenocarcinoma, breast carcinoma, renal cell carcinoma) will be classified according to standard oncological criteria to investigate its impact on neurological recovery and survival.

    Measured: preoperative

  7. History of Preoperative Oncologic Treatment and Surgery

    Information on prior chemotherapy, radiotherapy, immunotherapy, and spinal or non-spinal surgeries will be documented to assess their association with surgical outcomes and functional recovery.

    Measured: preoperative

  8. Anatomical Location and Extent of Spinal Tumor Involvement

    The vertebral level of metastasis, degree of bony destruction, and tumor extension into surrounding structures will be determined via imaging and intraoperative findings. These features will be analyzed in relation to postoperative ASIA outcomes.

    Measured: preoperative

  9. Pain Intensity Score

    Pain severity will be assessed preoperatively using the Visual Analog Scale (VAS), a 0-10 scale where higher scores indicate more severe pain. VAS scores will be used as a functional and prognostic indicator.

    Measured: Baseline and postoperative follow-ups (1, 3, 6 months)

  10. : Quality of Life Assessment Using QLQ-C30

    The patient's overall quality of life will be assessed using the EORTC QLQ-C30 (Version 3.0), a validated cancer-specific quality of life questionnaire developed by the European Organisation for Research and Treatment of Cancer. This instrument includes 30 items covering five functional domains (physical, role, cognitive, emotional, and social), three symptom domains (fatigue, pain, nausea/vomiting), a global health status/QoL scale, and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact). Each domain or symptom score will be linearly transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores for functional scales represent better functioning, while higher scores for symptom scales represent more severe symptoms.

    Measured: Baseline, 1, 3, 6 and 12 months postoperatively

  11. Epidural Spinal Cord Compression (ESCC) Grade and Neurological Responsibility Level

    The degree of spinal cord compression will be graded using the ESCC scale (grades 0-3) based on preoperative MRI, and the responsible spinal level (segment causing neurological dysfunction) will be identified. These factors will be analyzed for correlation with pre- and postoperative ASIA grade and recovery outcomes.

    Measured: preoperative

  12. Spinal Instability Neoplastic Score

    Spinal stability will be assessed using the Spinal Instability Neoplastic Score (SINS), which includes components such as pain, lesion location, bone quality, alignment, vertebral body collapse, and posterior involvement. The total score (0-18) will help stratify patients as stable, potentially unstable, or unstable and will be evaluated for its predictive value on surgical planning and outcomes.

    Measured: preoperative

  13. PET-CT Assessment: Solid Organ Metastases and Spinal Tumor Burden

    Whole-body PET-CT will be used to identify the presence of visceral organ metastases and quantify the number and distribution of involved spinal levels. This information will be used to assess systemic tumor burden and analyze its relationship with neurological recovery and overall prognosis.

    Measured: preoperative

  14. Preoperative ASIA Impairment Grade

    The ASIA (American Spinal Injury Association) Impairment Grade will be documented preoperatively to classify neurological status (Grade A to E) at baseline. This will serve as both a prognostic factor and reference for postoperative recovery analysis.

    Measured: preoperative

  15. Time from Incomplete Paralysis to Surgery

    For patients presenting with incomplete paralysis, the interval between the onset of neurological weakness and the surgical intervention will be recorded in hours or days to assess the relationship between timing and functional outcomes.

    Measured: preoperative

  16. Modified Ashworth Scale for Spasticity

    Muscle spasticity will be graded using the Modified Ashworth Scale, a 6-point scale (0 to 4, with 1+) that measures resistance during passive soft-tissue stretching. This will assess upper motor neuron involvement and serve as a baseline and outcome parameter.

    Measured: preoperative,3 month, 6 month,12 month

  17. Duration of Surgery

    The total operative time will be measured in minutes, from skin incision to wound closure. It will be used as a surrogate for surgical complexity and will be correlated with perioperative risk and outcomes.

    Measured: Intraoperative

  18. Surgical Location

    The anatomical spinal region (cervical, thoracic, lumbar, sacral) and specific vertebral levels subjected to decompression will be documented. These data will be used to assess the relationship between surgical site and neurological recovery.

    Measured: Intraoperative

  19. Intraoperative Blood Loss Volume

    The estimated amount of blood loss during surgery will be recorded in milliliters (mL). This variable reflects surgical invasiveness and will be correlated with transfusion requirements and postoperative complications.

    Measured: Intraoperative

  20. Use of Instrumented Internal Fixation

    Whether internal fixation devices (e.g., pedicle screws, rods, cages) were implanted will be documented (yes/no). This will be used to analyze the impact of mechanical stabilization on postoperative functional recovery.

    Measured: Intraoperative

  21. Tumor Resection Method

    The tumor removal method will be recorded as gross total resection, subtotal resection, or en bloc resection. The completeness of tumor removal will be analyzed for its association with local control and neurological outcomes.

    Measured: Intraoperative

  22. Postoperative Pathology Results

    Pathologic confirmation of the spinal metastatic lesion, including histologic type, surgical margins, and proliferation index (e.g., Ki-67), will be recorded. Pathology findings will be used for diagnostic confirmation and correlation with prognosis.

    Measured: Postoperative(within 20 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527728
Sponsor's protocol ID
2025SL079
Status last verified
Apr 2026
First submitted
10 Aug 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim CH, Chung CK, Jahng TA, Kim HJ. Resumption of ambulatory status after surgery for nonambulatory patients with epidural spinal metastasis. Spine J. 2011 Nov;11(11):1015-23. doi: 10.1016/j.spinee.2011.09.007. Epub 2011 Oct 14.

    PubMed 22000724
  • Kato S, Hozumi T, Takeshita K, Kondo T, Goto T, Yamakawa K. Neurological recovery after posterior decompression surgery for anterior dural compression in paralytic spinal metastasis. Arch Orthop Trauma Surg. 2012 Jun;132(6):765-71. doi: 10.1007/s00402-012-1475-x. Epub 2012 Feb 14.

    PubMed 22327407
  • Ohashi M, Hirano T, Watanabe K, Katsumi K, Shoji H, Sano A, Tashi H, Takahashi I, Wakasugi M, Shibuya Y, Endo N. Preoperative prediction for regaining ambulatory ability in paretic non-ambulatory patients with metastatic spinal cord compression. Spinal Cord. 2017 May;55(5):447-453. doi: 10.1038/sc.2016.145. Epub 2016 Oct 18.

    PubMed 27752060
  • Li S, Zhong N, Xu W, Yang X, Wei H, Xiao J. The impact of surgical timing on neurological outcomes and survival in patients with complete paralysis caused by spinal tumours: evaluation of surgery on patients with complete paralysis due to neoplastic epidural spinal cord compression. Bone Joint J. 2019 Jul;101-B(7):872-879. doi: 10.1302/0301-620X.101B7.BJJ-2018-1173.R1.

    PubMed 31256678
  • Younsi A, Riemann L, Ishak B, Scherer M, Unterberg AW, Zweckberger K. Feasibility of salvage decompressive surgery for pending paralysis due to metastatic spinal cord compression. Clin Neurol Neurosurg. 2021 Mar;202:106509. doi: 10.1016/j.clineuro.2021.106509. Epub 2021 Jan 22.

    PubMed 33540174

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Spinal Tumors and Spinal Cord Compression, run by Shanghai Changzheng Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Xu (+8613761278657, xuwei_spine@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Achieving Improvement in ASIA Impairment Grade at 1 Month Post-Surgery (time frame: Baseline (preoperative) to 1 month postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527728, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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