Clinical trial · Interventional
Minimally Invasive Surgery in Treating Patients With Spinal Tumors
Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
NCT01308489CI-TRIAL-00018164terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of subject response
Summary
Brief summary (as posted)
This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Spinal Cord Neoplasm | Adult Spinal Cord Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrent Adult Spinal Cord Neoplasm | Adult Spinal Cord Neoplasm | CURATED_BROADER | 0.78 |
| Spinal Bone Metastases | — | UNRESOLVED | — |
| Spinal Cord Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (posterior spinal tumor resection)
- description
- Patients undergo posterior spinal tumor resection on day 0.
- interventionNames
- Procedure: therapeutic conventional surgery
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- Arm II (anterior and posterior spinal tumor resection)
- description
- Patients undergo anterior and posterior tumor resection on day 0.
- interventionNames
- Procedure: therapeutic conventional surgery
- Procedure: quality-of-life assessment
Primary outcomes (4)
- measure
- Estimated blood loss (EBL); in milliliters (ml)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a diagnosis of primary, secondary or metastatic spine tumor and be undergoing any posterior spinal fusion with or without anterior fusion anywhere from occiput to sacrum * Greater than 3 month life expectancy * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: * Patients who are not surgical candidates for spine tumor removal, determined by the surgical team * Patients who have undergone previous spine surgery for tumor removal will be excluded * Patients with renal cell carcinoma * As there is an emphasis on blood loss and length of surgery, the critical variable for homogeneity is the vascularity of the tumor; hypervascular spine tumors are regarded by surgeons as amongst the most challenging of cases; by far the three most common hypervascular metastatic tumors are those arising from renal cell carcinoma, thyroid carcinoma and melanoma; these pathologies are usually regarded as a distinct subset for this reason in the majority of studies; because we rarely encounter the later two pathologies in our practice, we chose to include only the former; however, to further homogenize our study population we will exclude all three of the known hypervascular metastatic spine tumors * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
References
Publications (0)
Data not yet available
No reference posted for this study.