An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma

Department of Otorhinolaryngology, Eye & ENT Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Oropharynx Carcinoma
• Intervention / Treatment: Procedure: Surgery for early-stage OPC; Radiation: RT for early-stage OPC; Radiation: CRT for advanced OPC; Other: Surgery for advanced OPC; Procedure: Neoadjuvant treatment for advanced OPC

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Lei Tao, Dr.; Phone Number: +86 2164377134; Email: doctortaolei@163.com
• Study Contact Backup: Name: Xiaoke Zhu; Phone Number: +86 18221615406; Email: zxk199455@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Department of Otorhinolaryngology, Eye & ENT Hospital
      • Contact: Lei Tao, Dr.; Phone Number: +86 2164377134; Email: doctortaolei@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical treatment for early-stage OPC; Early-stage OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).	Procedure: Surgery for early-stage OPC; The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery (e.g., CO2 laser resection), and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered. Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., extranodal extension, perineural invasion or vascular invasion).
RT treatment for early-stage OPC; Early-stage OPC patients treated with radiotherapy (RT) according to proper indications (CSCO 2021 and NCCN 2021).	Radiation: RT for early-stage OPC; The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Early-stage OPC patients (T1-2,N0) enrolled in this group will be treated with RT.
CRT treatment for advanced OPC; Advanced OPC patients treated with chemoradiotherapy (CRT) according to proper indications (CSCO 2021 and NCCN 2021).	Radiation: CRT for advanced OPC; The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with CRT.
Surgical treatment for advanced OPC; Advanced OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).	Other: Surgery for advanced OPC; The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with surgical resection. The surgical techniques of the primary tumor include transoral robotic surgery, conventional transoral surgery, transoral laser microsurgery, and open surgery. Ipsilateral neck dissection should be performed for patients enrolled in this group. For patients with OPC at or approaching the midline, bilateral neck dissection should be strongly considered. Postoperative radiotherapy (RT) or system therapy/RT should be considered for patients with adverse features (e.g., pT3 or pT4 primary, pN2 or pN3 nodal disease, extranodal extension, or vascular invasion).
Neoadjuvant treatment for advanced OPC; Advanced OPC patients treated with neoadjuvant treatment according to proper indications (CSCO 2021 and NCCN 2021).	Procedure: Neoadjuvant treatment for advanced OPC; The treatment strategy for patients should be discussed by the multidisciplinary team with the goal of maximizing survival with preservation of appearance and function and planned based on the tumor extension as ascertained by clinical evaluation and careful interpretation of appropriate imaging examinations. Advanced OPC patients (T1-2,N1-3/T3-4,N0-3) enrolled in this group will be treated with neoadjuvant treatment. The subsequent treatments include RT, system therapy/RT, and surgical resection with or without postoperative adjuvant therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival	The time between the treatment and the date of death from any causes	Three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year local control survival	The time between the treatment and the first evidence of local recurrence	Three years
3-year regional control	The time between the treatment and the first evidence of regional recurrence	Three years
3-year disease specific survival	The time between the treatment and the date of death from oropharyngeal cancer	Three years
3-year disease free survival	The time between the treatment and the first evidence of disease recurrence, metastasis or death from any cause	Three years
3-year progress-free survival	The time between the treatment and the date of first documented disease progression or death from any cause	Three years
Quality of Life post treatment	Quality of life as assessed with the MD Anderson Dysphagia Inventory (MDADI)	One year and three years post treatment

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): March 31, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Treatment; Oropharynx carcinoma; Survival outcomes
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: FD-EENT-2022036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No