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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Neoplasms Blood Cell Count Neoplasm Staging Prognosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this 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.

No interventions assigned to this 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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No