Treatment outcomes for laryngeal and hypopharyngeal carcinoma
Official title: Department of Otorhinolaryngology, Eye & ENT Hospital
Run by Eye & ENT Hospital of Fudan University · NCT04908696 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | June 23, 2026 |
| Study ends | December 1, 2027 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT04908696 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Lei Tao
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Lei Tao, Dr.
- Email: doctortaolei@163.com
- Phone: 86 2164377134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.