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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • routines

    Procedure/Surgery

    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).

Treatment groups

1,000 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: TLM treatment for LC and PHC patients with early stage1 intervention
Group B: OPL treatment for LC and PHC patients with T1, T2, and T3 stages1 intervention
Group C: R treatment for LC and PHC patients with early stage1 intervention
Group D: TORS treatment for LC and PHC patients with early stage1 intervention
Group E: SPA treatment for LC and PHC patients with advanced stage1 intervention
Group F: CCR treatment for LC and PHC patients with advanced stage1 intervention
Group G: ARC treatment for LC and PHC patients with advanced stage1 intervention
Group H: ASRC treatment for LC and PHC patients with advanced stage1 intervention

Trial outcomes

Primary outcomes

1

3 - years overall survival

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

Time frame
Three years
2

3 - years disease specific survival

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

Time frame
Three years
3

3 - years laryngeal function preservation

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

Time frame
Three years

Secondary outcomes

1

3 - years disease free survival

the time between the treatment and the first evidence of disease recurrence, metastasis or death

Time frame
Three years
2

3- local control

the time between the treatment and the first evidence of local recurrence

Time frame
Three years
3

3- regional control

the time between the treatment and the first evidence of regional recurrence

Time frame
Three years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Changhai Hospital

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Fudan University

Collaborator

Shanghai Changzheng Hospital

Collaborator

RenJi Hospital

Collaborator

Shanghai 6th People's Hospital

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator