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)
N/A
N/A
Both
Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck, LA SCCHN
Trial Information
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)
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of Patients with Serious Adverse Reactions
Outcome Description:
Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Rajiv Rana, MD
Investigator Role:
Study Director
Investigator Affiliation:
Merck Ltd., India
Authority:
India: Drugs Controller General of India
Study ID:
EMR062202-539
NCT ID:
NCT01303237
Start Date:
February 2011
Completion Date:
Related Keywords:
- Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
- LA SCCHN
- LA SCCHN
- Cetuximab
- RT
- PMS
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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