Back to resultsA Prospective Study of Surgical Treatment Strategies for Chordoma
Primary Purpose
Chordoma of Spine, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resection surgery
Sponsored by
About this trial
This is an interventional treatment trial for Chordoma of Spine focused on measuring chordoma
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 70 ys, With a diagnosis of chordoma confirmed by pathology, Undergone surgical treatment in our hospital, Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent. Exclusion Criteria: Suffer from other tumors, Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.
Sites / Locations
- Xuanwu Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chordoma Patients
Arm Description
Chordoma Patients
Outcomes
Primary Outcome Measures
Excision Extension
Clinical and radiographic assessments of excision extension of tumor.
Secondary Outcome Measures
OS (Overall Survival)
Overall Survival of patient underwent surgery.
PFS (Progression-Free Survival)
Progression-Free Survival of patient underwent surgery.
DFS (Disease Free Survival)
Disease Free Survival of patient underwent surgery.
ORR (Objective Response Rate)
Objective Response Rate of patient underwent surgery.
Full Information
NCT ID
NCT05707767
First Posted
October 9, 2022
Last Updated
July 17, 2023
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT05707767
Brief Title
A Prospective Study of Surgical Treatment Strategies for Chordoma
Official Title
A Prospective Study of Surgical Treatment Strategies for Chordoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Chordoma is a rare but locally invasive cancer that arises from the embryonic notochord. Total resection is challenging in mobile spine because of the complex anatomy and bone invasion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chordoma of Spine, Surgery
Keywords
chordoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chordoma Patients
Arm Type
Experimental
Arm Description
Chordoma Patients
Intervention Type
Procedure
Intervention Name(s)
Resection surgery
Intervention Description
Patients undergo resection surgery in our hospital.
Primary Outcome Measure Information:
Title
Excision Extension
Description
Clinical and radiographic assessments of excision extension of tumor.
Time Frame
1 week after surgery.
Secondary Outcome Measure Information:
Title
OS (Overall Survival)
Description
Overall Survival of patient underwent surgery.
Time Frame
2 years
Title
PFS (Progression-Free Survival)
Description
Progression-Free Survival of patient underwent surgery.
Time Frame
2 years
Title
DFS (Disease Free Survival)
Description
Disease Free Survival of patient underwent surgery.
Time Frame
2 years
Title
ORR (Objective Response Rate)
Description
Objective Response Rate of patient underwent surgery.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between the ages of 18 and 70 ys,
With a diagnosis of chordoma confirmed by pathology,
Undergone surgical treatment in our hospital,
Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.
Exclusion Criteria:
Suffer from other tumors,
Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zan Chen, MD. PHD.
Phone
18131166269
Email
chenzan66@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
22300861
Citation
Walcott BP, Nahed BV, Mohyeldin A, Coumans JV, Kahle KT, Ferreira MJ. Chordoma: current concepts, management, and future directions. Lancet Oncol. 2012 Feb;13(2):e69-76. doi: 10.1016/S1470-2045(11)70337-0.
Results Reference
result
PubMed Identifier
34266694
Citation
Wedekind MF, Widemann BC, Cote G. Chordoma: Current status, problems, and future directions. Curr Probl Cancer. 2021 Aug;45(4):100771. doi: 10.1016/j.currproblcancer.2021.100771. Epub 2021 Jul 1.
Results Reference
result
PubMed Identifier
31243811
Citation
Yeter HG, Kosemehmetoglu K, Soylemezoglu F. Poorly differentiated chordoma: review of 53 cases. APMIS. 2019 Sep;127(9):607-615. doi: 10.1111/apm.12978.
Results Reference
result
PubMed Identifier
33567141
Citation
Kolz JM, Wellings EP, Houdek MT, Clarke MJ, Yaszemski MJ, Rose PS. Surgical treatment of primary mobile spine chordoma. J Surg Oncol. 2021 Apr;123(5):1284-1291. doi: 10.1002/jso.26423. Epub 2021 Feb 10.
Results Reference
result
PubMed Identifier
23744869
Citation
Williams BJ, Raper DM, Godbout E, Bourne TD, Prevedello DM, Kassam AB, Park DM. Diagnosis and treatment of chordoma. J Natl Compr Canc Netw. 2013 Jun 1;11(6):726-31. doi: 10.6004/jnccn.2013.0089.
Results Reference
result
Learn more about this trial
A Prospective Study of Surgical Treatment Strategies for Chordoma
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