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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck, LA SCCHN

Intervention / Treatment
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* Drug: Cetuximab + RT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria as per the product label for LA SCCHN approved by India Health Authority Unresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck Patient willing and able to give written Informed Consent Patient capable of complying with study data collection procedures Exclusion Criteria: Exclusion criteria as per the product label for LA SCCHN approved by India Health Authority
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cetuximab + RT|Cetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 3 years | 
| Progression Free Survival |  | 3 years | 
| Duration of Locoregional Disease Control |  | 3 years | 
| Overall Survival |  | 3 years | 
| Response Rate |  | 8 weeks (Post completion of treatment duration) | 
| Management of skin conditions due to treatment protocol |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LA SCCHN, Cetuximab, RT, PMS