A Prospective Study of Surgical Treatment Strategies for Chordoma

• Sponsor: Xuanwu Hospital, Beijing (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05707767
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 19.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chordoma of Spine; Surgery	Procedure: Resection surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Study of Surgical Treatment Strategies for Chordoma
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Excision Extension [1 week after surgery.]

   Clinical and radiographic assessments of excision extension of tumor.

Secondary Outcome Measures

1. OS (Overall Survival) [2 years]

   Overall Survival of patient underwent surgery.

2. PFS (Progression-Free Survival) [2 years]

   Progression-Free Survival of patient underwent surgery.

3. DFS (Disease Free Survival) [2 years]

   Disease Free Survival of patient underwent surgery.

4. ORR (Objective Response Rate) [2 years]

   Objective Response Rate of patient underwent surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xuanwu Hospital, Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xuanwu Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT05707767
• Other Study ID Numbers: XW-NS-CHORC
• First Posted: Feb 1, 2023
• Last Update Posted: Feb 1, 2023
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xuanwu Hospital, Beijing: chordoma
• Additional relevant MeSH terms: Chordoma

Study Results

No Results Posted as of Feb 1, 2023