A Prospective Study of Surgical Treatment Strategies for Chordoma

July 17, 2023 updated by: Xuanwu Hospital, Beijing
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100000
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chordoma Patients
Procedure: Resection surgery
Patients undergo resection surgery in our hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excision Extension
Time Frame: 1 week after surgery.
Clinical and radiographic assessments of excision extension of tumor.
1 week after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS (Overall Survival)
Time Frame: 2 years
Overall Survival of patient underwent surgery.
2 years
PFS (Progression-Free Survival)
Time Frame: 2 years
Progression-Free Survival of patient underwent surgery.
2 years
DFS (Disease Free Survival)
Time Frame: 2 years
Disease Free Survival of patient underwent surgery.
2 years
ORR (Objective Response Rate)
Time Frame: 2 years
Objective Response Rate of patient underwent surgery.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 9, 2022

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XW-NS-CHORC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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