An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma

Eye & ENT Hospital of Fudan University

Status: Enrolling

Conditions: Oropharynx Carcinoma

Treatments: Other: Surgery for advanced OPC; Procedure: Neoadjuvant treatment for advanced OPC; Radiation: CRT for advanced OPC; Radiation: RT for early-stage OPC; Procedure: Surgery for early-stage OPC

Study type: Observational

Funder types: Other

Identifiers

NCT05341479

FD-EENT-2022036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

200 participants in 5 patient groups

Surgical treatment for early-stage OPC

Description:

Early-stage OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).

Treatment:

Procedure: Surgery for early-stage OPC

RT treatment for early-stage OPC

Description:

Early-stage OPC patients treated with radiotherapy (RT) according to proper indications (CSCO 2021 and NCCN 2021).

Treatment:

Radiation: RT for early-stage OPC

CRT treatment for advanced OPC

Description:

Advanced OPC patients treated with chemoradiotherapy (CRT) according to proper indications (CSCO 2021 and NCCN 2021).

Treatment:

Radiation: CRT for advanced OPC

Surgical treatment for advanced OPC

Description:

Advanced OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).

Treatment:

Other: Surgery for advanced OPC

Neoadjuvant treatment for advanced OPC

Description:

Advanced OPC patients treated with neoadjuvant treatment according to proper indications (CSCO 2021 and NCCN 2021).

Treatment:

Procedure: Neoadjuvant treatment for advanced OPC