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IRCT20190112042328N1 IRCT 2019-02-01 Zistdaru Danesh Co. ® Evaluation the efficacy and safety of Cetuximab bio-similar compared to Erbitux in the patients with head and neck squamous cell carcinoma. A randomized, phase 3, two-armed, parallel group, double blind (patient and outcome assessor blinded), active control, non-inferiority clinical trial to assess the efficacy and safety of Cetuximab bio-similar (Zistdaru Danesh Co. ®) compared to Erbitux (Merck®) in the patients with head and neck squamous cell carcinoma. 2019-05-05 anticipated 163 Complete https://irct.ir/trial/36740 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization program is done by an online system (http://www.randomization.com) with the permuted block randomization method. The length of each block is 4 patients, which will be made up for a total of 163 patients. When the randomization is done, each patient receives a code that, by it, will be recognized in the study. The code will consist of two numbers (in accordance with the randomization number) and four letters (corresponding to the first two letters of the name and the first two letters of the last name). Randomization numbers are assigned sequentially. The random chain will be created, and the anonymous codes associated with each patient are affixed to drug labels and pre-assembled on the recruitment sites. After the patient enters the study, the prescribed code will be announced to the site and the corresponding drug will be prescribed to the patient, Blinding description: This study is a double-blind study. All treatment personnel and those involved in the study and patients are unaware of who is receiving which of the two drugs. Both study drugs have completely the same vial and packaging. The team that evaluates the study will be completely different from those involved in the treatment of the patients. 3 Head and Neck Squamous Cell Carcinoma (HNSCC). Intervention 1: Intervention group: Cetuximab bio-similar of Zistdaru Danesh Co. ® (100 mg/20 ml vial) starts with intravenous infusion one week before radiotherapy at an initial dose of 400 mg/m2 in 120 minutes. Then the weekly infusion of it is continued at a dose of 250 mg/m2 in 60 minutes up to 8 weeks. Before prescribing Cetuximab, Diphenhydramine (50 mg) or another H1 antagonist is prescribed. The administration of Cetuximab is discontinued in response to the allergy reaction of grade 3 and 4. Intervention 2: Control group: Erbitux of Merck® (100 mg/20 ml vial) starts with intravenous infusion one week before radiotherapy at an initial dose of 400 mg/m2 in 120 minutes. Then the weekly infusion of it is continued at a dose of 250 mg/m2 in 60 minutes up to 8 weeks. Before prescribing Erbitux, Diphenhydramine (50 mg) or another H1 antagonist is prescribed. The administration of Erbitux is discontinued in response to the allergy reaction of grade 3 and 4. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Seyed Hamed Hosseini
Unit 23, 4th floor, No. 1547., North Kargar Ave., Tehran
Tehran Iran (Islamic Republic of) 1417993337 +98 21 8896 3546 ctc@tums.ac.ir Tehran University of Medical Sciences scientific Farhad Samiei
Cancer Institute, Emam-Khomeini hospital, Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 1111111111 +98 21 8896 3546 samieifarhad@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years or older Patients with supraglottic and oral cavity cancer Head and neck cancers with involved local lymph nodes without specific primary origin Patients with stages 2, 3, and 4 non-metastatic nasopharyngeal cancer Patients with stages 3 and 4 oropharynx and larenxo hypopharynx cancer Minimum "Karnofsky performance" score should be 60. Organs function should be appropriate: (Platelete count≥100000, Serum creatinine≤1.2 mg% or Creatinine clearance≤50 mL/min, Total bilirubin≤1.5 mg/100 mL, Haemoglobine≥10gm/DL, Absolute neutrophil count≥1,500/mL, and normal liver function tests) 18 years no limit Both Sustained electrolyte disorders such as resistant hypomagnesemia Any proven pathology other than squamous cell carcinoma The presence of serious underlying lung disease Previous history of cancer and chemotherapy over the past three years Previous history of head and neck radiotherapy Breastfeeding Pregnancy All patients who can not be radiotheraped or there will be problems (such as scleroderma patients, anatomical problems based on the physician diagnosis, hemangiomas or localized lymphangitis, etc.) Treatment - Drugs Treatment - Drugs Intervention group: Cetuximab bio-similar of Zistdaru Danesh Co. ® (100 mg/20 ml vial) starts with intravenous infusion one week before radiotherapy at an initial dose of 400 mg/m2 in 120 minutes. Then the weekly infusion of it is continued at a dose of 250 mg/m2 in 60 minutes up to 8 weeks. Before prescribing Cetuximab, Diphenhydramine (50 mg) or another H1 antagonist is prescribed. The administration of Cetuximab is discontinued in response to the allergy reaction of grade 3 and 4. Control group: Erbitux of Merck® (100 mg/20 ml vial) starts with intravenous infusion one week before radiotherapy at an initial dose of 400 mg/m2 in 120 minutes. Then the weekly infusion of it is continued at a dose of 250 mg/m2 in 60 minutes up to 8 weeks. Before prescribing Erbitux, Diphenhydramine (50 mg) or another H1 antagonist is prescribed. The administration of Erbitux is discontinued in response to the allergy reaction of grade 3 and 4. Time to progression: is defined as the time from randomization until objective tumor progression. Timepoint: Monthly up to 4 months, then every 4 months up to two years after randomization. Method of measurement: Checklist (month). Progressive free survival; is defined as the time from randomization until objective tumor progression or death. Timepoint: Monthly up to 4 months, then every 4 months up to two years after randomization. Method of measurement: Checklist (month). Overall survival times; is defined as the time from randomization until death from any cause (in ITT population). Timepoint: Monthly up to 4 months, then every 4 months up to two years after randomization. Method of measurement: Checklist (month). Overall response rate; is defined as the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period (from the time of initial response until documented tumor progression). Timepoint: Monthly up to 4 months, then every 4 months up to two years after randomization. Method of measurement: Proportion. Safety outcome. Timepoint: Monthly up to 4 months, then every 4 months up to two years after randomization. Method of measurement: It will be measured based on side effects reports, the results of laboratory tests and vital signs. Side effects are assessed by CTC AE (v. 4.0) guideline of the American National Cancer Institute. Immunogenicity outcome. Timepoint: Before the administration of the drug and the first and second weeks, the first month, the twelfth month and the twenty-fourth month after the administration of the drug. Method of measurement: Measurement of anti-drug antibodies (ADA) and neutralising antibodies in 10 randomly selected individuals from each group. Zistdaru Danesh Co. ® Approved 2018-10-28 Ethics committee of Tehran University of Medical Sciences The central building of Tehran University of Medical Sciences, Corner of Vesal-e Shirazi Ave., Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)