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

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ClinicalTrials.gov Identifier: NCT02303457
Recruitment Status : Recruiting
First Posted : December 1, 2014
Last Update Posted : January 28, 2016
Sponsor:
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
Information provided by (Responsible Party):
Xuekui Liu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Glottis Procedure: CO2 Laser surgery Procedure: Open Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : July 2014
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CO2 laser surgery
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.
Procedure: CO2 Laser surgery
Patients were randomly assigned to CO2 laser surgery group and open Surgery group.

Open surgery

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.

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




Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. recurrence rate [ Time Frame: 5 years ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303457


Contacts
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Contact: xuekui liu, doctor (86-20) 8734 3768 liuxk@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: xuekui liu, doctor    (86-20) 8734 3768    liuxk@sysucc.org.cn   
Sponsors and Collaborators
Xuekui Liu
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Director: ye cao, doctor Sun Yat-sen University

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Responsible Party: Xuekui Liu, chief physician, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02303457     History of Changes
Other Study ID Numbers: 2014012
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Xuekui Liu, Sun Yat-sen University:
CO2 laser surgery
open surgery
multicenter prospective
randomized
controlled clinical studies
T1N0 squamous cell carcinoma of glottis with anterior commissure involved

Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell