Clinical trial NCT02211677: Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Neoplasms
Blood Cell Count
Neoplasm Staging
Prognosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years after diagnosis
Secondary outcomes:
measure: 5-year disease-free survival
timeFrame: 5 years after diagnosis
measure: 5-year recurrence-free survival
timeFrame: 5 years after diagnosis
measure: 5-year distant-free survival
timeFrame: 5 years after diagnosis
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The Fisrt Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui Province Hospital
state: Anhui
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shaoyang
country: China
facility: The Central Hospital of Shaoyang
state: Hunan
city: Luzhou
country: China
facility: The Affiliated Hospital of Luzhou Medical College
state: Sichuan
Study officials:
affiliation: Sun Yat-sen University
name: Yun-fei Xia, MD
role: PRINCIPAL_INVESTIGATOR
References: