Squamous Cell Carcinoma of GlottisNCT02303457
CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved
A study testing CO2 Laser surgery and Open Surgery in people with Squamous Cell Carcinoma of Glottis, run by Xuekui Liu at 1 site in China.
Trial summary
Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma of Glottis
- What is being tested?
- CO2 Laser surgery and Open Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1N0 SCC of glottic carcinoma with anterior commissure involve
- No nodal metastasis and distant metastasis
- All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery
- Expected lifetime>1 year
- Patients and families agreed to participate in the test and sign the informed consent
- Without cognitive impairment.
Who cannot join
- With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients
- Patients with pregnancy and lactation
- Have surgery contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
xuekui liu, doctor, (86-20) 8734 3768, liuxk@sysucc.org.cn
About this study
Official title: Multicenter, Prospective, Randomized and Controlled Clinical Study 0f CO2 Laser and Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved
Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.
- Conditions
- Squamous Cell Carcinoma of Glottis
- Being tested
- CO2 Laser surgery, Open Surgery
- Keywords
- CO2 laser surgery, open surgery, multicenter prospective, randomized, controlled clinical studies, T1N0 squamous cell carcinoma of glottis with anterior commissure involved
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 Laser surgeryProcedure or surgery
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
Open SurgeryProcedure or surgery
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
| Study group | Role | What they receive |
|---|---|---|
| CO2 laser surgery | Experimental | CO2 Laser surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved. All patients, under general anesthesia, underwent endoscopic excision of the lesion using a carbon dioxide (CO2) laser (Sharplan 100) coupled with a microscope (Zeiss) set to an output power of between 5 and 12 W in superpulse mode. The lesion's resection was accomplished in a radical fashion, with a free margin of 2 mm. For lesions which involved the anterior commissure, the excision plane always uncovered the cartilage. Receives: Procedure: CO2 Laser surgery |
| Open surgery | Other | Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved.
open surgery :Frontolateral Vertical Partial Laryngectomy or laryngofissure with cordectomy was accomplished in a radical fashion, with a free margin of 2 mm. Receives: Procedure: Open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Measured: 5 years
Secondary outcomes (1)
recurrence rate
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of GlottisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuekui Liu
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor-investigator, Xuekui Liu, Sun Yat-sen University
- Investigators
- ye cao, doctor, Study director, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303457
- Sponsor's protocol ID
- 2014012
- Status last verified
- Jan 2016
- First submitted
- 2 Nov 2014
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized and Controlled Clinical Study 0f CO2 Laser and Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved
- ClinicalTrials.gov ID
- NCT02303457
- Acronym / sponsor ID
- 2014012
- Conditions
- Squamous Cell Carcinoma of Glottis
- Keywords
- CO2 laser surgery, open surgery, multicenter prospective, randomized, controlled clinical studies, T1N0 squamous cell carcinoma of glottis with anterior commissure involved
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Xuekui LiuUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- Jul 2014
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- 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.
Open surgery and CO2 laser surgery are both established treatment modalities for T1N0 glottic carcinoma. It is controversial for T1N0 glottic carcinoma with anterior commissure involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 laser surgery | Experimental | Procedure: CO2 Laser surgeryCO2 Laser surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved. All patients, under general anesthesia, underwent endoscopic excision of the lesion using a carbon dioxide (CO2) laser (Sharplan 100) coupled with a microscope (Zeiss) set to an output power of between 5 and 12 W in superpulse mode. The lesion's resection was accomplished in a radical fashion, with a free margin of 2 mm. For lesions which involved the anterior commissure, the excision plane always uncovered the cartilage. |
| Open surgery | Other | Procedure: Open SurgeryOpen Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved. open surgery :Frontolateral Vertical Partial Laryngectomy or laryngofissure with cordectomy was accomplished in a radical fashion, with a free margin of 2 mm. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- T1N0 SCC of glottic carcinoma with anterior commissure involve
- No nodal metastasis and distant metastasis
- All patients must have CT/MR and electronic laryngoscope test before surgery and after surgery
- Expected lifetime>1 year
- Patients and families agreed to participate in the test and sign the informed consent
Key exclusion criteria (3 listed)
- With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients
- Patients with pregnancy and lactation
- Have surgery contraindications
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 |
|---|---|---|
| CO2 Laser surgeryPatients were randomly assigned to CO2 laser surgery group and open Surgery group. | Procedure or surgery | CO2 laser surgery |
| Open SurgeryPatients were randomly assigned to CO2 laser surgery group and open Surgery group. | Procedure or surgery | Open surgery |
Primary outcome
disease-free survival
Time frame: 5 years
1 secondary outcome
recurrence rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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.
ye cao, doctor study director
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 Laser surgery and Open Surgery in people with Squamous Cell Carcinoma of Glottis, run by Xuekui Liu 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 6 inclusion and 3 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 28 Jan 2016. 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?
Contact xuekui liu, doctor ((86-20) 8734 3768, liuxk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2016.