Head and Neck Squamous Cell Carcinoma (HNSCC).
Conditions
Interventions
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
Sponsors
Zistdaru Danesh Co. ®
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Hamed Hosseini
Tehran University of Medical Sciences
Outcome results
None listed