Recurrent Nasopharyngeal Carcinoma
Conditions
Keywords
Nimotuzumab, IMRT, Radiation, Recurrent, Nasopharyngeal Carcinoma
Brief summary
The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.
Detailed description
The clinical efficacy of Nimotuzumab combined with radiotherapy has been shown in advanced nasopharyngeal cancer, which was significantly higher than radiotherapy alone. The efficacy of radiotherapy combined with Nimotuzumab has not been confirmed in recurrent nasopharyngeal cancer.In this study, Phase II clinical trials were performed. The patients were treated with Nimotuzumab which were used concurrently with IMRT. The efficacy and toxicity will be assessed.
Interventions
DRUGNimotuzumab
Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy
Sponsors
Sun Yat-sen University
Jiangxi Provincial Cancer Hospital
Zhejiang Cancer Hospital
Fujian Medical University Union Hospital
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment. 2. Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations. 3. Age 18-70. 4. At least one of the tumor lesions measurable. 5. Functional Status: PS (ECOG) \> 0-1. 6. Normal Bone Marrow Function: White blood cell count \> 4×109/L, hemoglobin \>90g/L, and platelet count \>100×109/L. 7. Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) \< 1.5 x ULN and serum creatinine \< 1.5 x ULN. 8. Life expectancy of more than 6 months. 9. All the patients signed the informed consent. 10. Follow up regularly and comply with test requirements.
Exclusion criteria
1. Patients with recurrent cervical lymph nodes alone. 2. Evidence of distant metastasis 3. The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy. 4. Creatinine clearance \< 30ml/min 5. Has received epidermal growth factor targeting therapy. 6. Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix). 7. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc. 8. Active systemic infection. 9. History of Serious lung or heart disease. 10. Drug or alcohol addiction. 11. Persons without capacity for civil conduct or persons with limited capacity for civil conduct. 12. The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study. 13. To receive chronic systemic immunotherapy or hormone therapy other than this study. 14. Women who are pregnant or breast feeding 15. Participation in other drugs clinical trials within 1 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients | Three month after patients subject to the treatment | The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. |
| Toxicity of this combined treatment for recurrent NPC patients | Three month after patients subject to the treatment | Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.Toxicity Criteria for Adverse Events version 3.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Progression free survival | Three years | — |
| Disease-free survival | Three years | Defined as the time in month from all treatment were finished to the date of disease progress is observed. |
| Overall survival | Three years | Defined as the time in month from diagnosis of recurrent NPC to the date of death is observed or to last follow-up visit. |
Countries
China
Contacts
Primary ContactSHAOJUN LIN, Dr.
Outcome results
None listed