NCT04908696

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

May 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
4.5 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

May 24, 2021

Last Update Submit

November 26, 2025

Conditions

Glottic CarcinomaSupraglottic CarcinomaSubglottic CarcinomaPyriform Sinus CarcinomaPostcricoid CarcinomaPosterior Pharyngeal Wall Carcinoma

Keywords

Laryngeal carcinomaHypopharyngeal carcinomaSurgeryLaryngeal function preservation treatment

Outcome Measures

Primary Outcomes (3)

  • 3 - years overall survival

    the time between the treatment and the date of death from any causes

    Three years

  • 3 - years disease specific survival

    the time between the treatment and the date of death from laryngeal carcinoma or hypohparyngeal carcinoma

    Three years

  • 3 - years laryngeal function preservation

    the time between the treatment and the date of laryngeal function preservation failure

    Three years

Secondary Outcomes (3)

  • 3 - years disease free survival

    Three years

  • 3- local control

    Three years

  • 3- regional control

    Three years

Study Arms (8)

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).

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).

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).

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.

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).

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).

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).

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).

Procedure: routines

Interventions

routinesPROCEDURE

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).

Also known as: Open partial laryngectomy with laryngeal function preservation, Radiotherapy, Transoral robotic surgery, Surgical treatment ± postoperative adjuvant therapy, Concurrent chemoradiotherapy, Neoadjuvant therapy + radiotherapy/chemoradiotherapy, Neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy
ARC treatment for LC and PHC patients with advanced stageASRC treatment for LC and PHC patients with advanced stageCCR treatment for LC and PHC patients with advanced stageOPL treatment for LC and PHC patients with T1, T2, and T3 stagesR treatment for LC and PHC patients with early stageSPA treatment for LC and PHC patients with advanced stageTLM treatment for LC and PHC patients with early stageTORS treatment for LC and PHC patients with early stage

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Tao

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Laryngeal NeoplasmsHypopharyngeal Neoplasms

Interventions

RadiotherapyChemoradiotherapyNeoadjuvant TherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Otorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic DiseasesPharyngeal NeoplasmsPharyngeal DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsCombined Modality TherapyDrug Therapy

Study Officials

  • Lei Tao, Dr.

    Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China

    STUDY CHAIR

Central Study Contacts

Lei Tao, Dr.

CONTACT

86 2164377134doctortaolei@163.com

Hongli Gong, Dr.

CONTACT

86 18917785176gonghlent@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 24, 2021

First Posted

June 1, 2021

Study Start

December 1, 2025

Primary Completion (Estimated)

June 23, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations

CN(1)