nasopharyngeal carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with newly histologically confirmed nasopharyngeal carcinoma; 2. Tumor staged as T3-4N0-3/T1-2N2-3 (according to the 7th AJCC edition); 3. No evidence of distant metastasis (M0); 4. ECOG PS 0-2; 5. Aged 18~70; 6. Male or female without pregnancy or lactation; 7. Adequate marrow: leucocyte count at least 4*10^9/L, neutrophil count at least 2*10^9/L, hemoglobin more than 90g/L and platelet count at least 100*10^9/L; 8. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) less than 1.5*upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) less than 2.5*ULN, and bilirubin less than ULN; 9. Adequate renal function: creatinine clearance at least 60 ml/min; 10. Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion criteria
Exclusion criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma; 2. Treatment with palliative intent; 3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer; 4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); 5. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume); 6. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes; 7. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose more than 1.5*ULN), and emotional disturbance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| short term effect;2-year PF; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;locoregional recurrent-free survival rate (LRRFS);distant metastasis-free survival rate(DMFS; | — |
Countries
China