NCT05707767

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 9, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 19, 2023

Status Verified

October 1, 2022

Enrollment Period

1.7 years

First QC Date

October 9, 2022

Last Update Submit

July 17, 2023

Conditions

Chordoma of SpineSurgery

Keywords

chordoma

Outcome Measures

Primary Outcomes (1)

  • Excision Extension

    Clinical and radiographic assessments of excision extension of tumor.

    1 week after surgery.

Secondary Outcomes (4)

  • OS (Overall Survival)

    2 years

  • PFS (Progression-Free Survival)

    2 years

  • DFS (Disease Free Survival)

    2 years

  • ORR (Objective Response Rate)

    2 years

Study Arms (1)

Chordoma Patients

EXPERIMENTAL

Chordoma Patients

Procedure: Resection surgery

Interventions

Resection surgeryPROCEDURE

Patients undergo resection surgery in our hospital.

Chordoma Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Suffer from other tumors,
  • Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100000, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22300861RESULT

  • 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.

    PMID: 34266694RESULT

  • 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.

    PMID: 31243811RESULT

  • 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.

    PMID: 33567141RESULT

  • 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.

    PMID: 23744869RESULT

MeSH Terms

Conditions

Chordoma

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

MastectomySurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2022

First Posted

February 1, 2023

Study Start

February 1, 2023

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

July 19, 2023

Record last verified: 2022-10

Locations

CN(1)