Nasopharyngeal Carcinoma
Conditions
Interventions
Group A:2 cycles of induction chemotherapy followed by concurrent chemoradiotherapy
Group B:3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed WHO type II or III nasopharyngeal carcinoma; 2. Stage III or IVA NPC (AJCC 8th edition); 3. Male or female aged 18–70 years; 4. Karnofsky performance score = 70; 5. Adequate renal and hepatic function: AST and ALT = 60 mL/min; 6. Adequate bone marrow function ( white blood cells > 4.0×10^9/L; absolute neutrophil count > 2.0 × 10^9/L, hemoglobin > 90g/L; platelets > 100×10^9/L); 7. Written informed consent with exact date obtained from the individual patients before certain proposed step; 8. Patients willing to be followed up regularly; 9. Compliance with the requirement of the trial.
Exclusion criteria
Exclusion criteria: 1. Previously received anti-tumor therapy including radiotherapy, chemotherapy or surgery; 2. Detection of distant metastasis before treatment; 3. Pregnancy or breast feeding; 4. Informed consent refusal; 5. Patients unable to be followed up regularly because of psychological, social, familial, or geographical reasons; 6. Simultaneous participation in another clinical study (on study treatment); 7. Known allergy to anticipated chemotherapy drugs; 8. Accompanied by serious uncontrollable infection or medical diseases; 9. Inadequate organ function, such as decompensated failure of the heart, lungs, kidneys, or liver, leading to intolerance to radiotherapy or chemotherapy; 10. Laboratory examination: total bilirubin > 1.5 × upper limit of normal (ULN); AST and (or) ALT > 2.5 × ULN and ALP > 2.5 × ULN; 11. Conditions that may affect the administration, distribution, metabolism, or excretion (ADME) of the drug: such as psychiatric disorders, central nervous system disorders, chronic diarrhea, ascites and hydrothorax; 12. Long-term treatment with immunosuppressor after organ transplantation; 13. Other malignancy before inclusion, except for non-melanocytoma skin cancer, carcinoma in situ of the cervix unable to tolerate chemotherapy and already cured early stage of prostate cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival rate (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Overall survival (OS);Metastasis-free survival rate;Locoregional recurrence-free survival;Safety and adverse events;Living quality; | — |
Countries
China
Contacts
Public ContactGuo Xiang
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Outcome results
None listed