Clinical trial NCT05341479: An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma
Official title: Department of Otorhinolaryngology, Eye & ENT Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharynx Carcinoma
Keywords: Oropharynx carcinoma
Treatment
Survival outcomes
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This prospective, observational study involves patients with T1-T4 stages oropharyngeal carcinoma, and we aim to evaluate and compare the oncological outcomes of different clinical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled are also collected to assess their associations with treatment strategies and prognoses.

Brief summary: This is a prospective, observational study evaluating the effect and efficiency of different clinical treatments for patients with oropharyngeal carcinoma (OPC). The selection of treatment for individual patient is based on tumor characteristics (tumor size and tumor location), a complete assessment of therapeutic effects (treatment effectiveness, possible dysfunction after operation, function maintenance, complications, etc.), and the preferences of doctors and patients.

Detailed description: For early-stage oropharyngeal carcinoma (T1-2,N0), radiotherapy or resection of the primary tumor (transoral laser microsurgery, transoral robotic surgery, conventional transoral surgery, and open surgery) with ipsilateral or bilateral neck dissection are performed according to the guidelines of Chinese society of clinical oncology (CSCO, version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., extranodal extension, positive margins, perineural invasion or vascular invasion).

For advanced oropharyngeal carcinoma (T1-2,N1-3/T3-4,N0-3), chemoradiotherapy (CRT), resection of the primary tumor (transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery) with ipsilateral or bilateral neck dissection or neoadjuvant therapy with appropriate therapy (surgical resection, RT or CRT) are performed according to the CSCO guidelines (version 2021) and the NCCN guidelines (version 2021). Postoperative radiotherapy (RT) or chemoradiotherapy (CRT) should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, positive margins, perineural invasion or vascular invasion).

This study aims to evaluate and compare the clinical outcomes of different medical treatments in patients with same TNM stage disease, overall and stratified by HPV expression. Demographic and clinicopathological characteristics of patients enrolled were also collected to assess their associations with treatment strategies and prognoses. The rates of overall survival, disease specific survival, disease free survival, local control, regional control, and progress-free survival are analyzed in the present study.

Eligibility criteria: Inclusion Criteria:

* Oropharyngeal cancer: Base of Tongue/Tonsil/Posterior Pharyngeal Wall/Soft Palate;
* 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).

Primary outcomes:
measure: 3-year overall survival
timeFrame: Three years
Secondary outcomes:
measure: 3-year local control survival
timeFrame: Three years
measure: 3-year regional control
timeFrame: Three years
measure: 3-year disease specific survival
timeFrame: Three years
measure: 3-year disease free survival
timeFrame: Three years
measure: 3-year progress-free survival
timeFrame: Three years
measure: Quality of Life post treatment
timeFrame: One year and three years post treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Otorhinolaryngology, Eye & ENT Hospital
state: Shanghai
Study officials:
affiliation: Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China
name: Lei Tao, Dr.
role: STUDY_CHAIR
References: