CTRI/2010/091/000170
Recruiting
Phase 4
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)
Merck Specialities Pvt Ltd5th Floor Shiv Sagar Estate, Dr. Aniie Besant Road, WorliMumbai 4000180 sites100 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Merck Specialities Pvt Ltd5th Floor Shiv Sagar Estate, Dr. Aniie Besant Road, WorliMumbai 400018
- Enrollment
- 100
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
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
Investigators
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