Overview

This trial is active, not recruiting.

Condition nasopharyngeal cancer
Treatments nimotuzumab, placebo plus chemoradiotherapy
Phase phase 3
Target EGFR
Sponsor Biotech Pharmaceutical Co., Ltd.
Start date October 2009
End date May 2016
Trial size 480 participants
Trial identifier NCT01074021, BT-CT-001

Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
nimotuzumab
Nimotuzumab:(200mg/w,weekly, 7-8 weeks, one week before radiotherapy) Radiotherapy: IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks. CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times,on days 2, 23, 44 during the radiotherapy)
(Placebo Comparator)
placebo plus chemoradiotherapy
Placebo treatment:4 bottles/w,weekly, 7-8 weeks, one week before radiotherapy Radiotherapy: IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks. CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times,on days 2, 23, 44 during the radiotherapy)

Primary Outcomes

Measure
To determine the local-regional control rates of the disease in the advanced nasopharyngeal cancer patients subject to the treatment with Nimotuzumab in combination with chemoradiation
time frame: 3 months after the Nimotuzumab treatment finished
To determine the safety of the treatment with Nimotuzumab in combination with chemoradiation
time frame: within study period

Secondary Outcomes

Measure
To determine the Disease-free survival、Tumor control probability、Distant recurrence rate in the patients subject to the treatment at years 1,2,3
time frame: 3 year
To determine the Progression free suivival、Diease free survival、Overall survival in the patients subject to the treatment
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Joined the study voluntary and signed informed consent form - Age 18-70,both genders. - Nasopharyngeal cancer was confirmed by pathology. - Nasopharyngeal cancer 2008 Stages: Ⅲ/Ⅳa. - Primary lesions can measurable. - Karnofsky Performance Scale >70. - Life expectancy of more than 6 months. - Use of an effective contraceptive method for women when there is a risk of pregnancy during the study. - Haemoglobin≥100g/L ,WBC ≥4×109/L, platelet count≥100×109/L - Hepatic function:ALAT、ASAT< 1.5 x ULN, TBIL< 1.5 x ULN - Renal function: Creatinine < 1.5 x ULN Exclusion Criteria: - Evidence of distant metastasis - Primary lesions or lymph node have been operated (except of operation for biopsy) - Previous radiotherapy - Received other anti EGFR monoclonal antibody treatment - Previous chemotherapy or immunization therapy - Other malignant tumor (except of Non-melanoma Skin Cancer or carcinoma in situ of cervix) - Participation in other interventional clinical trials within 1 month - Peripheral neuropathy is more than I stage - Pregnant or breast-feeding women and women who refused to take contraceptive method - History of serious allergic or allergy - History of Serious lung or heart disease - Refused or can't signed informed consent form - Drug abuse or alcohol addiction - Personality or psychiatric disease, and persons without capacity for civil conduct or persons with limited capacity for civil conduct

Additional Information

Official title A Prospective,Randomized,Double-Blind,Controlled,Multicenter,Phase III Study of Nimotuzumab in Combination With Chemotherapy and Radiotherapy for Patients With Local Advanced Nasopharyngeal Cancer
Description Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Biotech Pharmaceutical Co., Ltd..