Trial Information
An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Inclusion Criteria:
- The study inclusion criteria is as per the label for patients with
metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is
indicated for the treatment of patients with squamous cell cancer of the head and
neck in combination with platinum-based chemotherapy for recurrent and/or metastatic
disease."
- For each platinum-based chemotherapy, the related product labels approved by India
Health Authorities will also be followed strictly in terms of patient eligibility.
Exclusion Criteria:
- Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity
Criteria [NCI-CTC]) hypersensitivity reactions to Cetuximab are contraindicated for
Cetuximab
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
Outcome Description:
Safety variables will include the assessment of incidence and type of adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), incidence of withdrawals due to intolerability of cetuximab and severity of adverse events (AEs)
Outcome Time Frame:
From first infusion of cetuximab until 28 days after the last infusion.
Safety Issue:
Yes
Principal Investigator
Dr. Rajiv Rana
Investigator Role:
Study Director
Investigator Affiliation:
Merck Ltd., India
Authority:
India: Ministry of Health
Study ID:
EMR 062202-514
NCT ID:
NCT01142869
Start Date:
December 2009
Completion Date:
April 2016
Related Keywords:
- Carcinoma, Squamous Cell
- Carcinoma, Squamous Cell
- Erbitux
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms