Clinical trial NCT04908696: Clinical Treatments in Specialized Disease of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)
Official title: Department of Otorhinolaryngology, Eye & ENT Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glottic Carcinoma
Supraglottic Carcinoma
Subglottic Carcinoma
Pyriform Sinus Carcinoma
Postcricoid Carcinoma
Posterior Pharyngeal Wall Carcinoma
Keywords: Laryngeal carcinoma
Hypopharyngeal carcinoma
Surgery
Laryngeal function preservation treatment
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Fudan University
name: Shanghai Changzheng Hospital
name: RenJi Hospital
name: Shanghai 6th People's Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2021-06-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cohort study involve laryngeal cancer and hypopharyngeal cancer patients with T1 -T4 stages, and we plan to observe the oncologic outcomes from different clinical treatments.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 3 - years overall survival
timeFrame: Three years
measure: 3 - years disease specific survival
timeFrame: Three years
measure: 3 - years laryngeal function preservation
timeFrame: Three years
Secondary outcomes:
measure: 3 - years disease free survival
timeFrame: Three years
measure: 3- local control
timeFrame: Three years
measure: 3- regional control
timeFrame: Three years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Lei Tao
state: Shanghai
Study officials:
affiliation: Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China
name: Lei Tao, Dr.
role: STUDY_CHAIR
References: