A Post Marketing Surveillance Study to Assess the Safety and Efficacy of Cetuximab Plus Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN)
This is a prospective, non-randomized, observational, single arm, cohort study, wherein 200
patients of unresectable LA SCCHN will be enrolled. The eligibility of the patients will be
decided by the Investigators based on the locally approved label. The patients will be
treated with Cetuximab in combination with RT for a duration of 8 weeks and then followed up
for 3 years. The objectives of this study are to record safety and efficacy information on
the treatment combination in the general population.
Observational Model: Cohort, Time Perspective: Prospective
Number of Patients with Serious Adverse Reactions
Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
Rajiv Rana, MD
Merck Ltd., India
India: Drugs Controller General of India