Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: 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)
Study ID: NCT01303237
Interventions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Omega Hospital, Hyderabad, Andhra Pradesh, India
Shanti Chandra Family Clinic, Hyderabad, Andhra Pradesh, India
Swarna Sai Hospital, Hyderabad, Andhra Pradesh, India
Dr. Nikhil's Clinic, Secunderabad, Andhra Pradesh, India
Arogya Multispeciality Clinic, Mangalore, Bangalore, India
Aastha Oncology Associates, Ahmedabad, Gujarat, India
Navneet Memorial Centre, Ahmedabad, Gujarat, India
Meharbai TATA Memorial Hospital, Bistupur, Jamshedpur, India
Dr. T. P. Sahoo's Clinic, Bhopal, Madhya Pradesh, India
Ruby Hall Clinic, Pune, Maharashtra, India
Dr S M Karandikar Hospital, Pune, Maharashtra, India
Dwidal Nursing Home, Pune, Maharashtra, India
Regional cancer center, Sheikpura, Patna, India
Grecian Superspeciality Hospital, Mohali, Punjab, India
Harmony Health Care, Mohali, Punjab, India
Bhagwan Mahaveer Cancer Hospital & Research Center, Jaipur, Rajasthan, India
SMS Hospital, Jaipur, Rajasthan, India
Cancer Care Centre, Jaipur, Rajasthan, India
Balaji Clinic & General Hospital, Jaipur, Rajasthan, India
Royal Cancer Institute and Research Centre, Kanpur, Uttar Pradesh, India
SMH Curie Cancer Centre, New Delhi, Uttar Pradesh, India
Bengal Oncology, Kolkata, West Bengal, India
Apollo Gleneagles Cancer Hospital, Kolkata, West Bengal, India
Oncologist & Palliative Care Specialist Clinic, Kolkata, West Bengal, India
Dr. Meenu's Clinic, Delhi, , India
Contact Details
Name: Rajiv Rana, MD
Affiliation: Merck Ltd., India
Role: STUDY_DIRECTOR
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