En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
NCT ID: NCT06120426
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
182 participants
OBSERVATIONAL
2023-07-01
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Total en bloc spondylectomy for spinal oligometastases
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.
total en bloc spondylectomy
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.
Separation surgery combined with radiotherapy for spinal oligometastases
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.
No interventions assigned to this group
Interventions
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total en bloc spondylectomy
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.
Eligibility Criteria
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Inclusion Criteria
* 2\) Age range from 18 to 75 years old, regardless of gender.
* 3\) Within conservative treatment, the patient still has uncontrollable pain, metastatic cancer lesions that still progress, spinal instability/potential instability, or symptoms of spinal cord/nerve compression.
* 4\) After the patient underwent Positron Emission Tomography-Computed Tomography (PET-CT) examination, it was indicated that there were no more than 3 metastatic organs and no more than 5 metastatic lesions in the whole body of cancer. Among them, there was at least 1 spinal metastasis and at most 5 spinal metastases.
* 5\) Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis.
* 6\) The expected survival period is ≥ 6 months.
* 7)No other surgical contraindications
Exclusion Criteria
* 2\) Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment.
* 3\) Severe heart, lung, liver, kidney or other diseases affecting the surgery.
* 4\) Having cognitive impairment, sensory aphasia, and inability to understand basic instructions.
* 5\) Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment.
* 6\) Infectious diseases.
* 7\) Refuse to follow up or participate.
* 8\) The researchers determine that the patients are not suitable for enrollment this clinical trail.
18 Years
75 Years
ALL
Yes
Sponsors
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Peking University Third Hospital
OTHER
Peking University People's Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Zhejiang University
OTHER
Tianjin Hospital
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
The Third Affiliated Hospital of Southern Medical University
OTHER_GOV
Shanghai Changzheng Hospital
OTHER
Responsible Party
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Jianru Xiao
shanghaiczh
Locations
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Shanghai Changzheng hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Barzilai O, Laufer I, Yamada Y, Higginson DS, Schmitt AM, Lis E, Bilsky MH. Integrating Evidence-Based Medicine for Treatment of Spinal Metastases Into a Decision Framework: Neurologic, Oncologic, Mechanicals Stability, and Systemic Disease. J Clin Oncol. 2017 Jul 20;35(21):2419-2427. doi: 10.1200/JCO.2017.72.7362. Epub 2017 Jun 22.
Barzilai O, McLaughlin L, Amato MK, Reiner AS, Ogilvie SQ, Lis E, Yamada Y, Bilsky MH, Laufer I. Predictors of quality of life improvement after surgery for metastatic tumors of the spine: prospective cohort study. Spine J. 2018 Jul;18(7):1109-1115. doi: 10.1016/j.spinee.2017.10.070. Epub 2017 Nov 6.
Chang JH, Shin JH, Yamada YJ, Mesfin A, Fehlings MG, Rhines LD, Sahgal A. Stereotactic Body Radiotherapy for Spinal Metastases: What are the Risks and How Do We Minimize Them? Spine (Phila Pa 1976). 2016 Oct 15;41 Suppl 20(Suppl 20):S238-S245. doi: 10.1097/BRS.0000000000001823.
Kumar N, Madhu S, Bohra H, Pandita N, Wang SSY, Lopez KG, Tan JH, Vellayappan BA. Is there an optimal timing between radiotherapy and surgery to reduce wound complications in metastatic spine disease? A systematic review. Eur Spine J. 2020 Dec;29(12):3080-3115. doi: 10.1007/s00586-020-06478-5. Epub 2020 Jun 15.
Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Gronemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. doi: 10.1200/JCO.2004.03.097.
Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume JD, Ahrar K, Lopez R, Safran H, DiPetrillo T. Percutaneous radiofrequency ablation of painful osseous metastases: a multicenter American College of Radiology Imaging Network trial. Cancer. 2010 Feb 15;116(4):989-97. doi: 10.1002/cncr.24837.
Murali N, Turmezei T, Bhatti S, Patel P, Marshall T, Smith T. What is the effectiveness of radiofrequency ablation in the management of patients with spinal metastases? A systematic review and meta-analysis. J Orthop Surg Res. 2021 Nov 6;16(1):659. doi: 10.1186/s13018-021-02775-x.
D'Souza M, Gendreau J, Feng A, Kim LH, Ho AL, Veeravagu A. Robotic-Assisted Spine Surgery: History, Efficacy, Cost, And Future Trends. Robot Surg. 2019 Nov 7;6:9-23. doi: 10.2147/RSRR.S190720. eCollection 2019.
Kaoudi A, Capel C, Chenin L, Peltier J, Lefranc M. Robot-Assisted Radiofrequency Ablation of a Sacral S1-S2 Aggressive Hemangioma. World Neurosurg. 2018 Aug;116:226-229. doi: 10.1016/j.wneu.2018.05.060. Epub 2018 May 17.
Other Identifiers
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2023SL050
Identifier Type: -
Identifier Source: org_study_id
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