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

Carcinoma, Squamous Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02916368
• Other study ID #: PDHNSCC-01609
• Status: Not yet recruiting
• Phase: Phase 1
• First received: September 26, 2016
• Last updated: September 27, 2016
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: September 2016
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate		3 years	No