En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
1 other identifier
observational
182
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedNovember 13, 2023
November 1, 2023
2 years
November 2, 2023
November 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
after surgery until death due to primary disease or responsible segment
Secondary Outcomes (5)
Local Control Rate(LRC)
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.
Brief Pain inventory
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
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
1 month, 3 months, 6 months, and 12 months after surgery.
Study Arms (2)
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.
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.
Interventions
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
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.
You may qualify if:
- \) Be able to sign written informed consent.
- \) Age range from 18 to 75 years old, regardless of gender.
- \) 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.
- \) 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.
- \) Imaging examinations (enhanced MRI, enhanced CT, X-ray) indicate the presence of spinal metastasis.
- \) The expected survival period is ≥ 6 months.
- )No other surgical contraindications
You may not qualify if:
- \) Primary tumors of the spine or multiple tumors of the body, with\>3 metastatic organs and\>5 metastatic sites.
- \) Previously underwent spinal surgery, or received radiotherapy for the responsible segment of this treatment.
- \) Severe heart, lung, liver, kidney or other diseases affecting the surgery.
- \) Having cognitive impairment, sensory aphasia, and inability to understand basic instructions.
- \) Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment.
- \) Infectious diseases.
- \) Refuse to follow up or participate.
- \) The researchers determine that the patients are not suitable for enrollment this clinical trail.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Changzheng Hospitallead
- Peking University Third Hospitalcollaborator
- Peking University People's Hospitalcollaborator
- Henan Cancer Hospitalcollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Sun Yat-sen Universitycollaborator
- Zhejiang Universitycollaborator
- Tianjin Hospitalcollaborator
- The First Affiliated Hospital of Nanchang Universitycollaborator
- The Third Affiliated Hospital of Southern Medical Universitycollaborator
Study Sites (1)
Shanghai Changzheng hospital
Shanghai, Shanghai Municipality, 200003, China
Related Publications (10)
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.
PMID: 33538338RESULTBarzilai 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.
PMID: 28640703RESULTBarzilai 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.
PMID: 29122701RESULTChang 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.
PMID: 27488294RESULTKumar 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.
PMID: 32556627RESULTGoetz 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.
PMID: 14722039RESULTDupuy 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.
PMID: 20041484RESULTMurali 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.
PMID: 34742319RESULTD'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.
PMID: 31807602RESULTKaoudi 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.
PMID: 29777897RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- shanghaiczh
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 7, 2023
Study Start
July 1, 2023
Primary Completion
July 1, 2025
Study Completion (Estimated)
July 1, 2027
Last Updated
November 13, 2023
Record last verified: 2023-11