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RATIONALE
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun-fei Xia, MD | Contact | +8618665031162 | xiayf@sysucc.org.cn | |
| Hui Chang, MD | Contact | +8613480295989 | changhui@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yun-fei Xia, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fisrt Affiliated Hospital of Bengbu Medical College | Suspended | Bengbu | Anhui | 233004 | China | |
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| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| 5 years after diagnosis |
| 5-year distant-free survival | The period until distant metastasis is detected. | 5 years after diagnosis |
| Anhui Province Hospital |
| Suspended |
| Hefei |
| Anhui |
| 230001 |
| China |
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| The First Affiliated Hospital of Guangzhou Medical University | Suspended | Guangzhou | Guangdong | 510120 | China |
| The Central Hospital of Shaoyang | Suspended | Shaoyang | Hunan | 422000 | China |
| The Affiliated Hospital of Luzhou Medical College | Suspended | Luzhou | Sichuan | 646000 | China |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |