An Observational Study to evaluate the safety and efficacy of Cetuximab in combination with platinum-based chemotherapy, in the first-line therapy of recurrent/ metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Phase 4
- Registration Number
- CTRI/2010/091/000170
- Lead Sponsor
- Merck Specialities Pvt Ltd5th Floor Shiv Sagar Estate, Dr. Aniie Besant Road, WorliMumbai 400018
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
The study inclusion criteria is as per the local SPC: ?Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.?
For each platinum-based chemotherapy, the related product labels approved by India Health Authorities should also be followed strictly in terms of patient eligibility.
Exclusion Criteria
Patients with known severe (grade 3 or 4; NCI-CTC) hypersensitivity reactions to
Cetuximab are contraindicated for Cetuximab
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability evaluated based on the incidence and severity of adverse eventsTimepoint: At the end of study
- Secondary Outcome Measures
Name Time Method 1.Response rate <br>2.Disease Control Rate (DCR)<br>3. Progression Free Survival (PS)<br>4.Overall Survival (OS)Timepoint: At the end of the study