Glottic CarcinomaNCT04908696
Clinical Treatments in Specialized Diseases of Laryngeal Carcinoma (LC) and Hypopharyngeal Carcinoma (HPC)
An observational study of Glottic Carcinoma and Supraglottic Carcinoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glottic Carcinoma, Supraglottic Carcinoma, Subglottic Carcinoma
- What is being tested?
- routines
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Lei Tao
Shanghai, Shanghai Municipality, 200031
Hongli Gong, Dr., 86 18917785176, gonghlent@126.com
About this study
Official title: Department of Otorhinolaryngology, Eye & ENT Hospital
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.
Read the 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.
- Conditions
- Glottic Carcinoma, Supraglottic Carcinoma, Subglottic Carcinoma, Pyriform Sinus Carcinoma, Postcricoid Carcinoma, Posterior Pharyngeal Wall Carcinoma
- Being tested
- routines
- Keywords
- Laryngeal carcinoma, Hypopharyngeal carcinoma, Surgery, Laryngeal function preservation treatment
- Medical subject headings
- Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routinesProcedure or surgery
Also called Open partial laryngectomy with laryngeal function preservation, Radiotherapy, Transoral robotic surgery, Surgical treatment ± postoperative adjuvant therapy
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).
| Study group | Role | What they receive |
|---|---|---|
| TLM treatment for LC and PHC patients with early stage | TLM group: Laryngeal carcinoma (LC) (supraglottic type and glottic type) and hypopharyngeal carcinoma (HPC) (pyriform sinus and posterior pharyngeal wall) patients with T1 and T2 stages can be treated with transoral laser microsurgery (CO2 laser resection) for proper indications (NCCN 2020). Receives: Procedure: routines | |
| OPL treatment for LC and PHC patients with T1, T2, and T3 stages | OPL group: Open partial laryngectomy with laryngeal function preservation is performed for patients with laryngeal carcinoma (LC) (supraglottic type, glottic type, and subglottic type) and hypopharyngeal carcinoma (PHC) (pyriform sinus, postcricoid, and posterior pharyngeal wall) with proper indications (NCCN 2020). Receives: Procedure: routines | |
| R treatment for LC and PHC patients with early stage | R group: radiotherapy is treated for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications (NCCN 2020). Receives: Procedure: routines | |
| TORS treatment for LC and PHC patients with early stage | TORS group: transoral robotic surgery is performed for proper laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications. Receives: Procedure: routines | |
| SPA treatment for LC and PHC patients with advanced stage | SPA group: surgical treatment (S) ± postoperative adjuvant (PA) therapy is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). Receives: Procedure: routines | |
| CCR treatment for LC and PHC patients with advanced stage | CCR group: concurrent chemoradiotherapy (CCR) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). Receives: Procedure: routines | |
| ARC treatment for LC and PHC patients with advanced stage | ARC group: neoadjuvant therapy (A) + radiotherapy/chemoradiotherapy (RC) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). Receives: Procedure: routines | |
| ASRC treatment for LC and PHC patients with advanced stage | ASRC group: neoadjuvant therapy (A) + surgery (S) + radiotherapy (R) or chemoradiotherapy (C) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). Receives: Procedure: routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 - years overall survival
the time between the treatment and the date of death from any causes
Measured: Three years
3 - years disease specific survival
the time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma
Measured: Three years
3 - years laryngeal function preservation
the time between the treatment and the date of laryngeal function preservation failure
Measured: Three years
Secondary outcomes (3)
3 - years disease free survival
the time between the treatment and the first evidence of disease recurrence, metastasis or death
Measured: Three years
3- local control
the time between the treatment and the first evidence of local recurrence
Measured: Three years
3- regional control
the time between the treatment and the first evidence of regional recurrence
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Dec 2025 (estimated)
- Primary completion23 Jun 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glottic CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University, Shanghai Changzheng Hospital, RenJi Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, LeiTao, Eye & ENT Hospital of Fudan University
- Investigators
- Lei Tao, Dr., Study chair, Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908696
- Sponsor's protocol ID
- LC & HPC T121
- Status last verified
- Nov 2025
- First submitted
- 24 May 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Otorhinolaryngology, Eye & ENT Hospital
- ClinicalTrials.gov ID
- NCT04908696
- Acronym / sponsor ID
- LC & HPC T121
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Changhai Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University, Shanghai Changzheng Hospital, RenJi Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 23 Jun 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| TLM treatment for LC and PHC patients with early stage | – | Procedure: routinesTLM group: Laryngeal carcinoma (LC) (supraglottic type and glottic type) and hypopharyngeal carcinoma (HPC) (pyriform sinus and posterior pharyngeal wall) patients with T1 and T2 stages can be treated with transoral laser microsurgery (CO2 laser resection) for proper indications (NCCN 2020). |
| OPL treatment for LC and PHC patients with T1, T2, and T3 stages | – | Procedure: routinesOPL group: Open partial laryngectomy with laryngeal function preservation is performed for patients with laryngeal carcinoma (LC) (supraglottic type, glottic type, and subglottic type) and hypopharyngeal carcinoma (PHC) (pyriform sinus, postcricoid, and posterior pharyngeal wall) with proper indications (NCCN 2020). |
| R treatment for LC and PHC patients with early stage | – | Procedure: routinesR group: radiotherapy is treated for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications (NCCN 2020). |
| TORS treatment for LC and PHC patients with early stage | – | Procedure: routinesTORS group: transoral robotic surgery is performed for proper laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with early stage with proper indications. |
| SPA treatment for LC and PHC patients with advanced stage | – | Procedure: routinesSPA group: surgical treatment (S) ± postoperative adjuvant (PA) therapy is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). |
| CCR treatment for LC and PHC patients with advanced stage | – | Procedure: routinesCCR group: concurrent chemoradiotherapy (CCR) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). |
| ARC treatment for LC and PHC patients with advanced stage | – | Procedure: routinesARC group: neoadjuvant therapy (A) + radiotherapy/chemoradiotherapy (RC) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). |
| ASRC treatment for LC and PHC patients with advanced stage | – | Procedure: routinesASRC group: neoadjuvant therapy (A) + surgery (S) + radiotherapy (R) or chemoradiotherapy (C) is performed for laryngeal carcinoma (LC) and hypopharyngeal carcinoma (PHC) patients with advanced stage with proper indications (NCCN 2020). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routinesAlso: Open partial laryngectomy with laryngeal function preservation, Radiotherapy, Transoral robotic surgery, Surgical treatment ± postoperative adjuvant therapyFor 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). | Procedure or surgery | ARC treatment for LC and PHC patients with advanced stage, ASRC treatment for LC and PHC patients with advanced stage, CCR treatment for LC and PHC patients with advanced stage, OPL treatment for LC and PHC patients with T1, T2, and T3 stages, R treatment for LC and PHC patients with early stage, SPA treatment for LC and PHC patients with advanced stage, TLM treatment for LC and PHC patients with early stage, TORS treatment for LC and PHC patients with early stage |
Primary outcome
3 - years overall survival
Time frame: Three years
the time between the treatment and the date of death from any causes
3 - years disease specific survival
Time frame: Three years
the time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma
3 - years laryngeal function preservation
Time frame: Three years
the time between the treatment and the date of laryngeal function preservation failure
3 secondary outcomes
3 - years disease free survival
Time frame: Three years
3- local control
Time frame: Three years
3- regional control
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Tao, Dr. study chair
Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glottic Carcinoma and Supraglottic Carcinoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Tao, Dr. (86 2164377134, doctortaolei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 - years overall survival (time frame: Three years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.