Overview

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

Status:
Terminated
Trial end date:
2014-08-05
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck KGaA
Merck KGaA, Darmstadt, Germany
Collaborator:
Merck Ltd., India
Treatments:
Cetuximab
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