Evaluation the efficacy and safety of Cetuximab bio-similar compared to Erbitux in the patients with head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC).
- Registration Number
- IRCT20190112042328N1
- Lead Sponsor
- Zistdaru Danesh Co. ®
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 163
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)
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.)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method