Nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:1. Induction chemotherapy stage:
Experimental group(chronotherapy) : gemcitabine 1000mg/m2, ivgtt d1, d8, all administered at 08:00-08:30
Cisplatin 80mg/m2, intravenously pumped, d1, 10:00-22:00 constant pumping. Once every 3 weeks for a total of 3 cycles.
2. Simultaneous chemoradiotherapy
Experimental group: 100mg/m2 cisplatin, intrave
Control group:1. Induction chemotherapy stage:
Control group (standard treatment) : gemcitabine 1000mg/m2, ivgtt d1, d8
Cisplatin 80mg/m2, ivgtt, d1. Once every 3 weeks for a total of 3 cycles.
2. Simultaneous chemoradiotherapy stage:
Control group: Cisplatin 100mg/m2,ivgtt, d1, started on the same day or the second da
Sponsors
Affiliated Cancer Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed patients who did not receive radiotherapy or chemotherapy before the start of the clinical trial 2. Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated or undifferentiated, i.e., WHO type II or III). 3. Patients with stage III and IVa (UICC/AJCC Stage 8) (except patients with T3N0). 4. Men or non-pregnant women 5. Age =18 and 70 7. White blood cells (WBC) =4×109 /L, hemoglobin (HGB) =90 g/L, platelets (PLT) =100×109 /L. (or within the normal range of laboratory values) 8. Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 1.5 times the upper limit of normal value (ULN); Total bilirubin =1.5×ULN. 9. Renal function: creatinine clearance =60ml/min or serum creatinine =1.5×ULN. 10. The patient agrees to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The pathological type was WHO keratinized squamous cell carcinoma or basal squamous cell carcinoma. 2. Treatment is palliative. 3. A history of malignant neoplasms, with the exception of well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ. 4. Prior radiation therapy (except for non-melanoma skin cancer and previous lesions outside the target area of radiation therapy). 5. The primary and cervical metastases have been treated with chemotherapy or surgery (except diagnostic treatment). 6. With other serious diseases, it may bring greater risk or affect the compliance of the test. Examples: unstable heart disease requiring treatment, kidney failure, severe nephritis, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and mental illness.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence of nausea/vomiting ; quality of life;Distant metastasis-free survival;Immune function; | — |
Primary
| Measure | Time frame |
|---|---|
| 3-year recurrence-free survival rate;Overall Survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactFeng Jin
Affiliated Cancer Hospital of Guizhou Medical University
Outcome results
None listed