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

• Conditions: Pyriform Sinus Carcinoma; Postcricoid Carcinoma; Supraglottic Carcinoma; Subglottic Carcinoma; Glottic Carcinoma; Posterior Pharyngeal Wall Carcinoma

• Registration Number: NCT04908696
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Study First Posted: 2021-06-01
• Last Update Posted: 2021-06-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3 - years disease specific survival	Three years	the time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma
3 - years overall survival	Three years	the time between the treatment and the date of death from any causes
3 - years laryngeal function preservation	Three years	the time between the treatment and the date of laryngeal function preservation failure

Secondary Outcome Measures

Name	Time	Method
3- local control	Three years	the time between the treatment and the first evidence of local recurrence
3 - years disease free survival	Three years	the time between the treatment and the first evidence of disease recurrence, metastasis or death
3- regional control	Three years	the time between the treatment and the first evidence of regional recurrence

Trial Locations

Locations (1)

Lei Tao; 🇨🇳 Shanghai, Shanghai, China