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

Eye & ENT Hospital of Fudan University

Status: Enrolling

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

Treatments: Procedure: routines

Study type: Observational

Funder types: Other

Identifiers

NCT04908696

LC & HPC T121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,000 participants in 8 patient groups

TLM treatment for LC and PHC patients with early stage

Description:

TLM group: Laryngeal carcinoma (LC) (supraglottic type and glottic type) and hypopharyngeal carcinoma (HPC) (pyriform sinus and posterior pharyngeal wall) patients with T1 and T2 stages can be treated with transoral laser microsurgery (CO2 laser resection) for proper indications (NCCN 2020).

Treatment:

Procedure: routines

OPL treatment for LC and PHC patients with T1, T2, and T3 stages

Description:

OPL group: Open partial laryngectomy with laryngeal function preservation is performed for patients with laryngeal carcinoma (LC) (supraglottic type, glottic type, and subglottic type) and hypopharyngeal carcinoma (PHC) (pyriform sinus, postcricoid, and posterior pharyngeal wall) with proper indications (NCCN 2020).

Treatment:

Procedure: routines

R treatment for LC and PHC patients with early stage

Description:

R group: radiotherapy is treated for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications (NCCN 2020).

Treatment:

Procedure: routines

TORS treatment for LC and PHC patients with early stage

Description:

TORS group: transoral robotic surgery is performed for proper laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications.

Treatment:

Procedure: routines

SPA treatment for LC and PHC patients with advanced stage

Description:

SPA group: surgical treatment (S) ± postoperative adjuvant (PA) therapy is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

Treatment:

Procedure: routines

CCR treatment for LC and PHC patients with advanced stage

Description:

CCR group: concurrent chemoradiotherapy (CCR) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

Treatment:

Procedure: routines

ARC treatment for LC and PHC patients with advanced stage

Description:

ARC group: neoadjuvant therapy (A) + radiotherapy/chemoradiotherapy (RC) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

Treatment:

Procedure: routines

ASRC treatment for LC and PHC patients with advanced stage

Description:

ASRC group: neoadjuvant therapy (A) + surgery (S) + radiotherapy (R) or chemoradiotherapy (C) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020).

Treatment:

Procedure: routines