NCT02303457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

10 years

First QC Date

November 2, 2014

Last Update Submit

January 27, 2016

Conditions

Squamous Cell Carcinoma of Glottis

Keywords

CO2 laser surgeryopen surgerymulticenter prospectiverandomizedcontrolled clinical studiesT1N0 squamous cell carcinoma of glottis with anterior commissure involved

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    5 years

Secondary Outcomes (1)

  • recurrence rate

    5 years

Study Arms (2)

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.

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.

Procedure: Open Surgery

Interventions

CO2 Laser surgeryPROCEDURE

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

CO2 laser surgery
Open SurgeryPROCEDURE

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

Open surgery

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • ye cao, doctor

    Sun Yat-sen University

    STUDY DIRECTOR

Central Study Contacts

xuekui liu, doctor

CONTACT

(86-20) 8734 3768liuxk@sysucc.org.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

November 2, 2014

First Posted

December 1, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

CN(1)