Blood Cell Count, Nasopharyngeal Neoplasms, Neoplasm Staging, Prognosis
Conditions
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.
Interventions
None listed
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 years after diagnosis | The period until any event (death, local recurrence or distant metastasis) is detected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year disease-free survival | 5 years after diagnosis | The period until local recurrence or distant metastasis is detected. |
| 5-year recurrence-free survival | 5 years after diagnosis | The period until local recurrence is detected. |
| 5-year distant-free survival | 5 years after diagnosis | The period until distant metastasis is detected. |
Countries
China
Contacts
Primary ContactYun-fei Xia, MD
Backup ContactHui Chang, MD
Outcome results
None listed