Back to resultsCO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved
Primary Purpose
Squamous Cell Carcinoma of Glottis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CO2 Laser surgery
Open Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of Glottis focused on measuring CO2 laser surgery, open surgery, multicenter prospective, randomized, controlled clinical studies, T1N0 squamous cell carcinoma of glottis with anterior commissure involved
Eligibility Criteria
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
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
CO2 laser surgery
Open surgery
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
disease-free survival
Secondary Outcome Measures
recurrence rate
Full Information
NCT ID
NCT02303457
First Posted
November 2, 2014
Last Updated
January 27, 2016
Sponsor
Xuekui Liu
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
1. Study Identification
Unique Protocol Identification Number
NCT02303457
Brief Title
CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Recruiting
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuekui Liu
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
402 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CO2 laser surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Open surgery
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
CO2 Laser surgery
Intervention Description
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
Intervention Type
Procedure
Intervention Name(s)
Open Surgery
Intervention Description
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
Primary Outcome Measure Information:
Title
disease-free survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
recurrence rate
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuekui liu, doctor
Phone
(86-20) 8734 3768
Email
liuxk@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ye cao, doctor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuekui liu, doctor
Phone
(86-20) 8734 3768
Email
liuxk@sysucc.org.cn
12. IPD Sharing Statement
Learn more about this trial
CO2 Laser and Open Surgery for T1N0 Glottic SCC With Anterior Commissure Involved
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