Clinical Treatments in Specialized Disease of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)

Glottic Carcinoma Clinical Trial

Official title:

Department of Otorhinolaryngology, Eye & ENT Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908696
• Other study ID #: LC & HPC T121
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2021
• Source: Eye & ENT Hospital of Fudan University
• Contact: Lei Tao, Dr.
• Phone: 86 2164377134
• Email: doctortaolei[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery (CO2 laser resection), open partial laryngectomy (vertical partial laryngectomy, cricohyoidoepiglottopexy, cricohyoidopexy, horizontal partial laryngectomy), partial hypopharyngectomy, radiotherapy, and transoral robotic surgery were performed for patients with proper indications. For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, concurrent chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy were performed for patients with proper indications. This study seek to analyze and compare the clinical ouctomes of different treatments for the same T stage disease of LC and HPC. The main end events involving overall survival rate, disease specific survival rate, and laryngeal function preservation rate were analyzed in this study. Beside, the events of disease free survival rate, local control rate, and regional control rate were assessed.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Carcinoma
• Glottic Carcinoma

Intervention

Procedure:
• routines
For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery (CO2 laser resection), open partial laryngectomy (vertical partial laryngectomy, cricohyoidoepiglottopexy, cricohyoidopexy, horizontal partial laryngectomy), partial hypopharyngectomy, radiotherapy, and transoral robotic surgery were performed for patients with proper indications (NCCN 2020). For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, concurrent chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy were performed for patients with proper indications (NCCN 2020).

Locations

Country	Name	City	State
China	Lei Tao	Shanghai	Shanghai

Sponsors (8)

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

Country where clinical trial is conducted

China, 

Outcome

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