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

Department of Otorhinolaryngology, Eye & ENT Hospital

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04908696
Enrollment
1000
Registered
2021-06-01
Start date
2025-12-01
Completion date
2027-12-01
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glottic Carcinoma, Postcricoid Carcinoma, Posterior Pharyngeal Wall Carcinoma, Pyriform Sinus Carcinoma, Subglottic Carcinoma, Supraglottic Carcinoma

Keywords

Laryngeal carcinoma, Hypopharyngeal carcinoma, Surgery, Laryngeal function preservation treatment

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.

Interventions

PROCEDUREroutines

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).

Sponsors

Changhai Hospital
CollaboratorOTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Fudan University
CollaboratorOTHER
Shanghai Changzheng Hospital
CollaboratorOTHER
RenJi Hospital
CollaboratorOTHER
Shanghai 6th People's Hospital
CollaboratorOTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Eye & ENT Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
3 - years overall survivalThree yearsthe time between the treatment and the date of death from any causes
3 - years disease specific survivalThree yearsthe time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma
3 - years laryngeal function preservationThree yearsthe time between the treatment and the date of laryngeal function preservation failure

Secondary

MeasureTime frameDescription
3 - years disease free survivalThree yearsthe time between the treatment and the first evidence of disease recurrence, metastasis or death
3- local controlThree yearsthe time between the treatment and the first evidence of local recurrence
3- regional controlThree yearsthe time between the treatment and the first evidence of regional recurrence

Countries

China

Contacts

Primary ContactLei Tao, Dr.
doctortaolei@163.com86 2164377134
Backup ContactHongli Gong, Dr.
gonghlent@126.com86 18917785176

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026