A Post-Marketing Surveillance Study to assess the safety and efficacy of Cetuximab plus Radiotherapy (RT) in Locally Advanced Squamous Cell Carcinoma of Head & Neck (LA SCCHN)
Phase 4
- Conditions
- Health Condition 1: null- Locally Advanced Unresectable Squamous Cell Carcinoma of Head & Neck Cancers (SCCHN)
- Registration Number
- CTRI/2011/091/000206
- Lead Sponsor
- Merck Specialities Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
The study inclusion & exclusion criteria are as per the local SPC: Cetuximab in combination with RT is indicated for the treatment of patients with Locally Advanced Squamous Cell Cancer of the Head and Neck.
Exclusion Criteria
For the prescription of Cetuximab (Erbitux®) the product label approved by India Health Authority should also be followed strictly in terms of patient eligibility.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety TolerabilityTimepoint: During Treatment duration & follow up of 3 years
- Secondary Outcome Measures
Name Time Method Response Rate<br>LocoRegional Control<br>DFS<br>OS (3 yrs)Timepoint: