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

Recruiting

• Conditions: Nasopharyngeal Neoplasms; Blood Cell Count; Prognosis; Neoplasm Staging

• Registration Number: NCT02211677
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-07
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20
• Primary Completion: 2019-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 720

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year overall survival	5 years after diagnosis	The period until any event (death, local recurrence or distant metastasis) is detected.

Secondary Outcome Measures

Name	Time	Method
5-year recurrence-free survival	5 years after diagnosis	The period until local recurrence is detected.
5-year disease-free survival	5 years after diagnosis	The period until local recurrence or distant metastasis is detected.
5-year distant-free survival	5 years after diagnosis	The period until distant metastasis is detected.

Trial Locations

Locations (6)

The Fisrt Affiliated Hospital of Bengbu Medical College; 🇨🇳 Bengbu, Anhui, China

The Affiliated Hospital of Luzhou Medical College; 🇨🇳 Luzhou, Sichuan, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Anhui Province Hospital; 🇨🇳 Hefei, Anhui, China

The Central Hospital of Shaoyang; 🇨🇳 Shaoyang, Hunan, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China