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.

A non-inferiority clinical trial to assess the efficacy and safety of Cetuximab bio-similar compared to Erbitux in the patients with head and neck squamous cell carcinoma.

This study is a phase 3, randomized (using permuted block randomization method), two-armed, double-blind, parallel, and active control clinical trial.

After the randomization, 98 of the eligible patients will receive Cetuximab and 65 patients will receive Erbitux. Patients in each group undergo radiotherapy one week after prescribing study drugs. Prescribing study drugs with radiotherapy will continue for up to 8 weeks. Blinding is done for all of the treatment staff, outcome assessors and patients.

Inclusion criteria: age 18 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, and organs function should be appropriate. Exclusion criteria: sustained electrolyte disorders such as resistant hypomagnesemia, any proven pathology other than squamous cell carcinoma, serious underlying lung disease, history of cancer and chemotherapy over the past three years, history of head and neck radiotherapy, breastfeeding, pregnancy, and all patients who can not be radiotheraped or there will be problems with it.

Intervention group: Cetuximab bio-similar (Zistdaru Danesh Co. ®) + Radiotherapy; Control group: Erbitux (Merck®) + Radiotherapy.

The primary outcome of the study is TTP (time to progression), defined as the time from randomization until objective tumor progression.

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.

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.

No more information.