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 (PMS LAD SCCHN)

Merck KGaA (EMD Serono)

Status: Terminated

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

Treatments: Drug: Cetuximab + RT

Study type: Observational

Funder types: Industry

Identifiers

NCT01303237

EMR062202-539

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Volunteers: No Healthy Volunteers

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