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
- Conditions
- Unresectable Locally Advanced Squamous Cell Carcinoma of Head and NeckLA SCCHN
- Registration Number
- NCT01303237
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 88
- 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 as per the product label for LA SCCHN approved by India Health Authority
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Patients with Serious Adverse Reactions 3 years Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
- Secondary Outcome Measures
Name Time Method Response Rate 8 weeks (Post completion of treatment duration) Progression Free Survival 3 years Overall Survival 3 years Duration of Locoregional Disease Control 3 years Management of skin conditions due to treatment protocol 3 years
Trial Locations
- Locations (25)
Cancer Care Centre
🇮🇳Jaipur, Rajasthan, India
Balaji Clinic & General Hospital
🇮🇳Jaipur, Rajasthan, India
Shanti Chandra Family Clinic
🇮🇳Hyderabad, Andhra Pradesh, India
Swarna Sai Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Arogya Multispeciality Clinic
🇮🇳Mangalore, Bangalore, India
Dr. T. P. Sahoo's Clinic
🇮🇳Bhopal, Madhya Pradesh, India
Aastha Oncology Associates
🇮🇳Ahmedabad, Gujarat, India
SMH Curie Cancer Centre
🇮🇳New Delhi, Uttar Pradesh, India
Bhagwan Mahaveer Cancer Hospital & Research Center
🇮🇳Jaipur, Rajasthan, India
SMS Hospital
🇮🇳Jaipur, Rajasthan, India
Omega Hospital
🇮🇳Hyderabad, Andhra Pradesh, India
Dr. Nikhil's Clinic
🇮🇳Secunderabad, Andhra Pradesh, India
Navneet Memorial Centre
🇮🇳Ahmedabad, Gujarat, India
Meharbai TATA Memorial Hospital
🇮🇳Bistupur, Jamshedpur, 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
Royal Cancer Institute and Research Centre
🇮🇳Kanpur, Uttar Pradesh, India
Bengal Oncology
🇮🇳Kolkata, West Bengal, India
Oncologist & Palliative Care Specialist Clinic
🇮🇳Kolkata, West Bengal, India
Apollo Gleneagles Cancer Hospital
🇮🇳Kolkata, West Bengal, India
Dr. Meenu's Clinic
🇮🇳Delhi, India
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India