nasopharyngeal carcinoma
Conditions
Interventions
Comprehensive treatment group:docetaxel plus cisplatin induction chemotherapy followed by cisplatin concurrent chemoradiotherapy and gemcitabine adjuvant chemotherapy
Sponsors
The Fifth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 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 18-70 years old; 6. With normal liver function test TBIL= ULN; ALTAST = 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. Distant metastases; 2. Previously treated (surgery, chemotherapy, radiotherapy, EGFR targeted therapy or immunotherapy); 3. Second malignancy within 5 years; 4. Precious therapy with an investigational agent; 5. Uncontrolled seizure disorder or other serious neurologic disease; 6. Allergic reaction (>=Grade III) to any drug including in this study; 7. Clinically significant cardiac or respiratory disease; 8. Creatinine clearance <30ml/min; 9. Drug or alcohol addiction; 10. Do not have full capacity for civil acts; 11. With severe complications or active infection; 12. Concurrent immunotherapy or hormone therapy for other diseases; 13. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| distant failure-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival rate;progression-free survival rate;Local-regional control rate;treatmen-related toxicity; | — |
Countries
China
Contacts
Public ContactPeijian, Peng
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed