Squamous Cell Carcinoma of Glottis Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 402 |
| Est. completion date | July 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| 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 |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | disease-free survival | 5 years | No | |
| Secondary | recurrence rate | 5 years | No |