Nasopharyngeal Carcinoma
Conditions
Brief summary
Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.
Interventions
DEVICERoutine intravenous drip
DRUGinduction chemotherapy
RADIATIONintensity-modulated radiation therapy
Sponsors
Feng Jing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions; 2. Karnofsky score≥70; 3. Age 18-70 years old, male or female; 4. No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment; 5. To understand this study and sign informed consent form.
Exclusion criteria
1. A distant metastasis; 2. Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study; 3. Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period; 4. Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety | 5 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with curative effect | 1 year |
Countries
China
Contacts
Primary ContactFeng Jin, Professor
Outcome results
None listed