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An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma

ClinicalTrials.gov ID NCT05341479
Sponsor Eye & ENT Hospital of Fudan University
Information provided by LeiTao, Eye & ENT Hospital of Fudan University (Responsible Party)
Last Update Posted 2022-04-22
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Study Overview

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.

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Official Title
Department of Otorhinolaryngology, Eye & ENT Hospital
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
Other Study ID Numbers
  • FD-EENT-2022036
Study Start (Actual)
2022-04-01
Primary Completion (Estimated)
2025-03-31
Study Completion (Estimated)
2025-07-01
Enrollment (Estimated)
200
Study Type
Observational

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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).
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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.
Ages Eligible for Study
18 Years to 90 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Observational Model : Other
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Whole blood, Tumor tissue (If available), Para-tumor tissue (If available)

Groups and Interventions

Groups/Cohorts Intervention/Treatment
Groups/Cohorts Surgical treatment for early-stage OPC
Early-stage OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).
Intervention/Treatment 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).

Groups/Cohorts RT treatment for early-stage OPC
Early-stage OPC patients treated with radiotherapy (RT) according to proper indications (CSCO 2021 and NCCN 2021).
Intervention/Treatment 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.

Groups/Cohorts CRT treatment for advanced OPC
Advanced OPC patients treated with chemoradiotherapy (CRT) according to proper indications (CSCO 2021 and NCCN 2021).
Intervention/Treatment 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.

Groups/Cohorts Surgical treatment for advanced OPC
Advanced OPC patients treated with surgery according to proper indications (CSCO 2021 and NCCN 2021).
Intervention/Treatment 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).

Groups/Cohorts Neoadjuvant treatment for advanced OPC
Advanced OPC patients treated with neoadjuvant treatment according to proper indications (CSCO 2021 and NCCN 2021).
Intervention/Treatment 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.

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
3-year overall survivalThe time between the treatment and the date of death from any causesThree years
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
3-year local control survivalThe time between the treatment and the first evidence of local recurrenceThree years
3-year regional controlThe time between the treatment and the first evidence of regional recurrenceThree years
3-year disease specific survivalThe time between the treatment and the date of death from oropharyngeal cancerThree years
3-year disease free survivalThe time between the treatment and the first evidence of disease recurrence, metastasis or death from any causeThree years
3-year progress-free survivalThe time between the treatment and the date of first documented disease progression or death from any causeThree years
Quality of Life post treatmentQuality of life as assessed with the MD Anderson Dysphagia Inventory (MDADI)One year and three years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Eye & ENT Hospital of Fudan University
Investigators
  • Study Chair:Lei Tao, Dr.,Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2022-04-18
First Submitted that Met QC Criteria
2022-04-18
First Posted
2022-04-22
Study Record Updates
Last Update Submitted that met QC Criteria
2022-04-18
Last Update Posted
2022-04-22
Last Verified
2022-04

More Information

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Keywords Provided by LeiTao, Eye & ENT Hospital of Fudan University
Additional Relevant MeSH Terms