Status:
TERMINATED
An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy in the First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Ltd., India
Conditions:
Carcinoma, Squamous Cell
Eligibility:
All Genders
Brief Summary
The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the firs...
Eligibility Criteria
Inclusion
- 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
- Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria \[NCI-CTC\]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab
Key Trial Info
Start Date :
December 31 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 5 2014
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01142869
Start Date
December 31 2009
End Date
August 5 2014
Last Update
May 8 2017
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Ambaa Hospitals
Hyderabad, Andhra Pradesh, India, 500008
2
Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, India, 500034
3
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, India, 500063
4
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, India, 500025