Chordoma of SpineNCT05707767
A Prospective Study of Surgical Treatment Strategies for Chordoma
A study testing Resection surgery in people with Chordoma of Spine and Surgery, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chordoma of Spine, Surgery
- What is being tested?
- Resection surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Suffer from other tumors,
- Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100000
Zan Chen, MD. PHD., 18131166269, chenzan66@163.com
About this study
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.
- Conditions
- Chordoma of Spine, Surgery
- Being tested
- Resection surgery
- Keywords
- chordoma
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection surgeryProcedure or surgery
Patients undergo resection surgery in our hospital.
| Study group | Role | What they receive |
|---|---|---|
| Chordoma Patients | Experimental | Chordoma Patients Receives: Procedure: Resection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excision Extension
Clinical and radiographic assessments of excision extension of tumor.
Measured: 1 week after surgery.
Secondary outcomes (4)
OS (Overall Survival)
Overall Survival of patient underwent surgery.
Measured: 2 years
PFS (Progression-Free Survival)
Progression-Free Survival of patient underwent surgery.
Measured: 2 years
DFS (Disease Free Survival)
Disease Free Survival of patient underwent surgery.
Measured: 2 years
ORR (Objective Response Rate)
Objective Response Rate of patient underwent surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Feb 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chordoma of SpineStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707767
- Sponsor's protocol ID
- XW-NS-CHORC
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22300861Wedekind 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.
PubMed 34266694Yeter HG, Kosemehmetoglu K, Soylemezoglu F. Poorly differentiated chordoma: review of 53 cases. APMIS. 2019 Sep;127(9):607-615. doi: 10.1111/apm.12978.
PubMed 31243811Kolz 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.
PubMed 33567141Williams 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.
PubMed 23744869
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Surgical Treatment Strategies for Chordoma
- ClinicalTrials.gov ID
- NCT05707767
- Acronym / sponsor ID
- XW-NS-CHORC
- Conditions
- Chordoma of Spine, Surgery
- Keywords
- chordoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chordoma Patients | Experimental | Procedure: Resection surgeryChordoma Patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Suffer from other tumors,
- Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection surgeryPatients undergo resection surgery in our hospital. | Procedure or surgery | Chordoma Patients |
Primary outcome
Excision Extension
Time frame: 1 week after surgery.
Clinical and radiographic assessments of excision extension of tumor.
4 secondary outcomes
OS (Overall Survival)
Time frame: 2 years
PFS (Progression-Free Survival)
Time frame: 2 years
DFS (Disease Free Survival)
Time frame: 2 years
ORR (Objective Response Rate)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Results publication: PubMed 22300861Walcott 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 publication: PubMed 34266694Wedekind 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 publication: PubMed 31243811Yeter 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 publication: PubMed 33567141Kolz 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 publication: PubMed 23744869Williams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resection surgery in people with Chordoma of Spine and Surgery, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excision Extension (time frame: 1 week after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05707767, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.