The Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell Carcinoma

• Conditions: Carcinoma, Squamous Cell

• Registration Number: NCT02916368
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors .Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.

Detailed Description

Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors. Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.

About this study ,inclusion criteria were the following parts:

the patients of poor differentiated HNSCC ; T1-4aN0-2M0; pathological examination: poor differentiated squamous cell carcinoma; initial treatment(primary, without surgery, radiotherapy and chemotherapy); range:18-70 years old; KPS\>80; hemogram and the function of main organ such as heart, lung, liver and kidney were normal; having the endoscopy, CT and MRI before formed into different groups; sign the informed consent file, good compliance.

AND the exclusion criteria were:

uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis; serious and uncontrollable infection; main organ system failure (including heart ,lung ,liver and kidney); reject training; high and moderate differentiated squamous cell carcinoma

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28
• Study Start: 2017-01
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients of poor differentiated HNSCC ;
• Patients within the stage of T1-4aN0-2M0;
• The pathological examination of the patients show poor differentiated squamous cell carcinoma;
• Patients with initial treatment(primary, without surgery, radiotherapy and chemotherapy);
• 18-70 years old;
• KPS>80;
• Hemogram and the function of main organ such as heart, lung, liver and kidney were normal
• Having the endoscopy, CT and MRI Signed the informed consent file, good compliance.

Exclusion Criteria

• Uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis;
• Serious and uncontrollable infection;
• Main organ system failure (including heart ,lung ,liver and kidney); reject training;
• High and moderate differentiated squamous cell carcinoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival rate	3 years