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Spots Global Cancer Trial Database for An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma

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Trial Identification

Brief Title: An Observational Study of Clinical Treatments for Patients With Oropharyngeal Carcinoma

Official Title: Department of Otorhinolaryngology, Eye & ENT Hospital

Study ID: NCT05341479

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Department of Otorhinolaryngology, Eye & ENT Hospital, Shanghai, Shanghai, China

Contact Details

Name: Lei Tao, Dr.

Affiliation: Department of Otorhinolaryngology, Eye & ENT Hospital, Fudan University, Shanghai, China

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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