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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 720

Contacts and Locations

• Study Contact: Name: Yun-fei Xia, MD; Phone Number: +8618665031162; Email: xiayf@sysucc.org.cn
• Study Contact Backup: Name: Hui Chang, MD; Phone Number: +8613480295989; Email: changhui@sysucc.org.cn

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Suspended
      • The Fisrt Affiliated Hospital of Bengbu Medical College
    • Hefei, Anhui, China, 230001
      • Suspended
      • Anhui Province Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Principal Investigator: Yun-fei Xia, MD
      • Contact: Yun-fei Xia, MD; Phone Number: +8618665031162; Email: xiayf@sysucc.org.cn
      • Sub-Investigator: Hui Chang, MD
    • Guangzhou, Guangdong, China, 510120
      • Suspended
      • The First Affiliated Hospital of Guangzhou Medical University
  • Hunan
    • Shaoyang, Hunan, China, 422000
      • Suspended
      • The Central Hospital of Shaoyang
  • Sichuan
    • Luzhou, Sichuan, China, 646000
      • Suspended
      • The Affiliated Hospital of Luzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the participants involved in our study are patients who are first diagnosed nasopharyngeal carcinoma pathologically and treated with radical radiotherapy or chemoradiotherapy in ourhospital from August 1st 2014 to July 31st 2015.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Low Risk Group; Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hb, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 1-4 called the low risk group.
Intermediate Risk Group; Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 5-11 called the intermediate risk group.
High Risk Group; Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 12-17 called the high risk group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year disease-free survival	The period until local recurrence or distant metastasis is detected.	5 years after diagnosis
5-year recurrence-free survival	The period until local recurrence is detected.	5 years after diagnosis
5-year distant-free survival	The period until distant metastasis is detected.	5 years after diagnosis

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 7, 2014

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplasms; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
• Other Study ID Numbers: B2014-002-01