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CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved

Multicenter, Prospective, Randomized and Controlled Clinical Study 0f CO2 Laser and Open Surgery for T1N0 Glottic Squamous Cell Carcinoma With Anterior Commissure Involved

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02303457
Enrollment
402
Registered
2014-12-01
Start date
2014-07-31
Completion date
2024-07-31
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

Interventions

Patients were randomly assigned to CO2 laser surgery group and open Surgery group.

PROCEDUREOpen Surgery

Patients were randomly assigned to CO2 laser surgery group and open Surgery group.

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
Third Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Xuekui Liu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* With severe cardiac insufficiency Liver and kidney function is not complete systemic infection patients * Patients with pregnancy and lactation * Have surgery contraindications

Design outcomes

Primary

MeasureTime frame
disease-free survival5 years

Secondary

MeasureTime frame
recurrence rate5 years

Countries

China

Contacts

Primary Contactxuekui liu, doctor
liuxk@sysucc.org.cn(86-20) 8734 3768

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026