Treatment outcomes for laryngeal and hypopharyngeal carcinoma
Department of Otorhinolaryngology, Eye & ENT Hospital
The study will see if different standard treatments—surgery, radiotherapy, transoral laser or robotic approaches, and combined therapies—lead to better survival and laryngeal function for patients with T1–T4 laryngeal or hypopharyngeal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04908696 on ClinicalTrials.gov |
What this trial studies
This multicenter observational cohort follows patients with laryngeal and hypopharyngeal carcinoma staged T1–T4 who receive treatments chosen according to 2020 NCCN guidelines. Early-stage patients (T1–T2) may receive transoral laser microsurgery, open partial laryngectomy, radiotherapy, or transoral robotic surgery, while advanced-stage patients (T3–T4) may receive surgery with or without adjuvant therapy, concurrent chemoradiotherapy, or neoadjuvant-based combined approaches. The study compares overall survival, disease-specific survival, disease-free survival, local and regional control, and laryngeal function preservation across treatment groups. Data are collected at major Shanghai centers affiliated with Fudan University and Shanghai Jiao Tong University.
Who should consider this trial
Good fit: Adults aged 18–90 with glottic, supraglottic, subglottic laryngeal carcinoma or pyriform sinus/postcricoid hypopharyngeal carcinoma staged T1–T4 and fit for standard treatments are appropriate candidates.
Not a fit: Patients with severe comorbid conditions that preclude standard therapy, known immunodeficiency/HIV, pregnancy, or inability to receive care at participating centers may not benefit from participation.
Why it matters
Potential benefit: If successful, the analysis could clarify which guideline-based treatments provide the best balance of survival and laryngeal function preservation for each T stage.
How similar studies have performed: Previous retrospective and observational series have compared surgical and non-surgical approaches with mixed survival results and variable effects on voice and swallowing, so this multicenter comparison extends existing evidence rather than introducing an untested approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Shanghai, Shanghai Municipality
- Lei Tao — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lei Tao, Dr.
- Email: doctortaolei@163.com
- Phone: 86 2164377134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.