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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 88
- Locations
- 25
- Primary Endpoint
- Number of Patients with Serious Adverse Reactions
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Patients with Serious Adverse Reactions
Time Frame: 3 years
Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
Secondary Outcomes
- Response Rate(8 weeks (Post completion of treatment duration))
- Progression Free Survival(3 years)
- Overall Survival(3 years)
- Duration of Locoregional Disease Control(3 years)
- Management of skin conditions due to treatment protocol(3 years)