Clinical trial NCT03666221: Nimotuzumab for Recurrent Nasopharyngeal Carcinoma
Official title: An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Nasopharyngeal Carcinoma
Keywords: Nimotuzumab
IMRT
Radiation
Recurrent
Nasopharyngeal Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Sun Yat-sen University
name: Jiangxi Provincial Cancer Hospital
name: Zhejiang Cancer Hospital
name: Fujian Medical University Union Hospital
First posted: 2018-09-11
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
timeFrame: Three month after patients subject to the treatment
measure: Toxicity of this combined treatment for recurrent NPC patients
timeFrame: Three month after patients subject to the treatment
Secondary outcomes:
measure: Local Progression free survival
timeFrame: Three years
measure: Disease-free survival
timeFrame: Three years
measure: Overall survival
timeFrame: Three years
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of radiation oncology, Fujian cancer hospital
state: Fujian
Study officials:
References: