This prospective, observational, multicentre, post marketing surveillance study will collect safety and efficacy information on patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) treated with Cetuximab and Radiotherapy (RT) based on the locally approved label.
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.
Study Type
OBSERVATIONAL
Enrollment
88
Cetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT
Omega Hospital
Hyderabad, Andhra Pradesh, India
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.
Time frame: 3 years
Response Rate
Time frame: 3 years
Progression Free Survival
Time frame: 3 years
Duration of Locoregional Disease Control
Time frame: 3 years
Overall Survival
Time frame: 3 years
Response Rate
Time frame: 8 weeks (Post completion of treatment duration)
Management of skin conditions due to treatment protocol
Time frame: 3 years
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