Nasopharyngeal Carcinoma
Conditions
Interventions
TP:Paclitaxel For Injection(Albumin Bound)combined with DDP induction chemotherapy followed by concurrent chemoradiotherapy
TPF: TPF combined with DDP induction chemotherapy followed by concurrent chemoradiotherapy
Sponsors
Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University
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. Primary care patients without anti-tumor therapy; 4. No history of other malignancy; 5. Male or female, age 18–70 years; 6. Adequate renal and hepatic function; 7. Adequate bone marrow function ( absolute neutrophil count = 2.0 × 10^9/L, hemoglobin = 90 g/L; platelets = 100 × 10^9/L ); 8. No severe heart, lung, liver, kidney and other important organ dysfunction; 9. Karnofsky performance score = 70; 10. Written informed consent with exact date obtained from the individual patients before certain proposed step.
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; 6. Simultaneous participation in another clinical study; 7. Known allergy to Paclitaxel For Injection(Albumin Bound)docetaxel, cisplatin, or 5-fluorouracil; 8. Accompanied by serious uncontrollable infection or medical diseases; 9. Inadequate organ function; 10. Laboratory examination: total bilirubin > upper limit of normal (ULN); AST and (or) ALT > 1.5 × ULN and ALP > 2.5 × ULN; 11. Conditions that may adversely affect treatment compliance: such as psychiatric disorders, central nervous system disorders, chronic diarrhea, ascites and hydrothorax; 12. Long-term treatment with immune-suppressor after organ transplantation; 13. Other malignancy before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-free survival (FFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Drug safety;Objective response rate (ORR);Living quality; | — |
Countries
China
Contacts
Public ContactGuo Xiang
Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University
Outcome results
None listed