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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04908696
Other study ID # LC & HPC T121
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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