nasopharyngeal carcinoma
Conditions
Interventions
Group 1:nimotuzumab concurrent with intensity modulated radiation therapy
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients recurrent at the primary site with or without lymph node recurrence within 6 months after the completion of radiotherapy; 2. Patients with histologically confirmed recurrence at the primary site, those with only marginal recurrence must be confirmed radiographically; 3. Aged 18-70, both genders; 4. At least one radiographically documented lesion assessable according to RECIST 1.0. Lesions; 5. ECOG performance status of 0 or 1; 6. Haemoglobin=100g/L, WBC =4×10^9/L, platelet count=100×10^9/L; 7. Hepatic and renal function:ALT/AST< 2.5 x ULN, TBIL< 1.5 x ULN, Creatinine < 1.5 x ULN; 8. Life expectancy of more than or equal to 6 months; 9. Joined the study voluntary and signed informed consent form; 10. Be willing and able to comply with the protocol procedures for the duration of the trial.
Exclusion criteria
Exclusion criteria: 1. Patients only recurrent at lymph node; 2. Evidence of distant metastasis; 3. Recurrent site has previously received chemotherapy, radiotherapy, surgery, immunization therapy; 4. creatinine clearance rate<30ml/min; 5. Received other anti EGFR monoclonal antibody treatment; 6. History of another malignancy within 5 years prior to starting study treatment(besides non-melanoma skin cancer and cervical cancer at early stage); 7. Serious complications, for example, Hypertension, coronary heart disease, diabetes and heart failure which could not be controlled by standard pharmacologic therapies; 8. Clinically significant ongoing infection; 9. History of Serious lung or heart disease; 10. Drug abuse or alcohol addiction; 11. Persons without capacity for civil conduct or persons with limited capacity for civil conduct; 12. Significant medical or psychiatric disease which makes the trial inappropriate for the subject in the Investigator's opinion; 13. Patients who are currently received chronic systemic immune therapy or hormone therapy; 14. Pregnant or breast-feeding women; 15. Participation in other interventional clinical trials within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| locoregionally relapse free survival rate;diatant metastatic free survival;overall survival;quality of life; | — |
Countries
China
Contacts
Public ContactLin Shaojun
Fujian Provincial Cancer Hospital
Outcome results
None listed