Nasopharyngeal Carcinoma
Conditions
Interventions
One:1. Induction chemotherapy with Loboplatin and 5-FU (LF)(3 weekly), LBP 30mg/m2 d1
d22, 5-Fu 4g/m2 120hciv, d1-5
d22-26
2. Concurrent chemoradiotherapy with Loboplatin and IMRT, LBP 30mg/m2, d43
d64
3. Radical radiotherapy: after two periods of induction chemotherapy of LF. PTVnx: 68-70Gy/30-32f PTVnd: 62-68Gy/30-32f PTV1: 60-64Gy/30-32f PTV2: 54-58Gy/30-32f
Two:1. Induction chemotherapy with cisplatin and 5-FU (PF)(3 weekly), P 80mg/m2 d1
d22. 5-Fu 4g/m2 120hciv. d1-5
2. Concurrent chemoradiotherapy with cisplatin and IMRT, P 80mg/m2, d43
3. Radical radiotherapy: after two periods of induction chemotherapy of PF. PTVnx: 68-70Gy/30-32f PTVnd: 62-68Gy/30-32f PTV1: 60-64Gy/30-32f PTV2: 54-58Gy/30-32f
Sponsors
Sun Yat-sen University Cancer Centre
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III; 2. Original clinical staged as III, IVa or IVb(according to the 7th AJCC edition); 3. Patients newly diagnosised without history of anti-tumor treament; 4. Without history of other malignant tumors; 5. Male or female,between 18-60 years old; 6?With normal liver function test TBIL= ULN;ALT?AST = 2.5×ULN;ALP= 5×ULN; 7. With normal renal function test Creatinine clearance >=80 mL/min; 8. With normal hematopoietic function test: ANC>=2*10^9/L, PLT >=100*10^9/L and HGB >=9g/dL; 9. Without severe important organs dysfunction such as heart, lung and so on; 10. PS<=2 score; 11. Patients must give signed informed consent.
Exclusion criteria
Exclusion criteria: 1. With history of anti-tumor treament,including chemotherapy?radiotherapy?surgery; 2. Patients have evidence of relapse or distant metastasis; 3. In pregnant or lactating Female; 4. Patients without signing informed consent; 5. Patients who can not cope with regular follow-up due to psychological, social, family and geographical reasons; 6. Receiving other clinical studies at the same time(treatment period in clinical studies); 7. Known to be likely allergic to chemotherapy drug being used; 8. With severe uncontrolled infections or medical disorders; 9. Major organ dysfunction, such as decompensated heart, lung, kidney, liver failure, unable to tolerate chemotherapy; 10. Laboratoty test: TBIL>ULN; AST and/or ALT>1.5ULN with ALP>2.5ULN; 11. With influential factors such as mental disorders, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc which may influence administration, distribution, metabolism, excretion and so on; 12. Long-term users of immunosuppressive agents after organ transplantation; 13. With a history of other malignancies before entering the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Drug Safety;Objective response rate;Quality of life; | — |
Countries
China
Contacts
Public ContactXiang Guo
Outcome results
None listed