Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma

Prognosis Clinical Trial

Official title:

Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction of TNM Staging System in Nasopharyngeal Carcinoma: A Prospective Multi-institutional Observation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02211677
• Other study ID #: B2014-002-01
• Status: Recruiting
• Start date: August 2014
• Est. completion date: December 2024

Study information

• Verified date: June 2018
• Source: Sun Yat-sen University
• Contact: Yun-fei Xia, MD
• Phone: +8618665031162
• Email: xiayf[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE

1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between actual clinical outcome and TNM stages because it is an anatomy-based system in which functional factors are not concerned.

2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study.

PURPOSE To validate that the prognostic index based on complete blood count and TNM system had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system alone.

Description:

Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until death or the end of the study. Comparison on survivals of the 3 groups will be made to validate the accuracy of the prognostic index. And comparison on prediction efficacy between prognostic index and TNM staging system will be made.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: December 2024
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Nasopharyngeal cancer patients diagnosed by pathology or cytology

• UICC/AJCC 2010 Stage T1-4 N0-3 M0

• Male or female patients with age between 18 and 75 years old

• Karnofsky Performance Scores = 60

• Expected survival = 3 months

• Without dysfunction of heart, lung, liver, kidney and hematopoiesis

Exclusion Criteria:

• Karnofsky Performance Status Score < 70'

• Radiotherapy uncompleted (= 1 fraction missing)

• Distant metastases before or during radiotherapy

• Without weekly complete blood count during radiotherapy

• Application of colony stimulating factor such as erythropoietin

• Signs of infection before radiotherapy.

Related Conditions & MeSH terms

• Blood Cell Count
• Nasopharyngeal Neoplasms
• Neoplasm Staging
• Neoplasms
• Prognosis

Locations

Country	Name	City	State
China	The Fisrt Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Anhui Province Hospital	Hefei	Anhui
China	The Affiliated Hospital of Luzhou Medical College	Luzhou	Sichuan
China	The Central Hospital of Shaoyang	Shaoyang	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year overall survival	The period until any event (death, local recurrence or distant metastasis) is detected.	5 years after diagnosis
Secondary	5-year disease-free survival	The period until local recurrence or distant metastasis is detected.	5 years after diagnosis
Secondary	5-year recurrence-free survival	The period until local recurrence is detected.	5 years after diagnosis
Secondary	5-year distant-free survival	The period until distant metastasis is detected.	5 years after diagnosis