Glottic Carcinoma Clinical Trial
Official title:
Department of Otorhinolaryngology, Eye & ENT Hospital
For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery, open partial laryngectomy, radiotherapy, and transoral robotic surgery were performed according to NCCN guidelines (2020). For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy performed according to NCCN guidelines (2020). This study plan to analyze the clinical ouctomes of different treatment for the same T stage disease. The overall survival rate, disease specific survival, disease free survival, local control, regional control, and laryngeal function preservation rate were analyzed in this study.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Laryngeal cancer: glottic type, supraglottic type, and subglottic type; hypopharyngeal cancer: pyriform sinus type, postcri-coid type, and posterior pharyngeal wall type. - T1, T2, T3, and T4 stage. - Age 18 - 90. - Male or female. - Good compliance. - No other severe related diseases that may impact the treatment (such as other tumors, severe heart, lung and central nervous system diseases, etc.). - Negative pregnancy test (for female patients with fertility). - Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients do not have fertility. Female patients with postmenopausal status. Exclusion Criteria: - Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases. - Patients with a known history of active tuberculosis (TB). - Pregnant women or lactating women. - The doctors believes that it is inappropriate for patients to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time [within the past year] or active suicidal ideation or behavior). |
Country | Name | City | State |
---|---|---|---|
China | Lei Tao | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Eye & ENT Hospital of Fudan University | Changhai Hospital, Fudan University, RenJi Hospital, Shanghai 6th People's Hospital, Shanghai Changzheng Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3 - years overall survival | the time between the treatment and the date of death from any causes | Three years | |
Primary | 3 - years disease specific survival | the time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma | Three years | |
Primary | 3 - years laryngeal function preservation | the time between the treatment and the date of laryngeal function preservation failure | Three years | |
Secondary | 3 - years disease free survival | the time between the treatment and the first evidence of disease recurrence, metastasis or death | Three years | |
Secondary | 3- local control | the time between the treatment and the first evidence of local recurrence | Three years | |
Secondary | 3- regional control | the time between the treatment and the first evidence of regional recurrence | Three years |
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