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
- Conditions
- Carcinoma, Squamous Cell
- Registration Number
- NCT01142869
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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 first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 133
- 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.
- Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria [NCI-CTC]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN. From first infusion of cetuximab until 28 days after the last infusion. 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)
- Secondary Outcome Measures
Name Time Method To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN. From first infusion of cetuximab until 28 days after the last infusion. Clinical efficacy will be assessed by best tumor response, disease control rate, progression-free survival and overall survival with cetuximab treatment.
Trial Locations
- Locations (28)
Bhagwan Mahaveer Cancer Hospital
🇮🇳Jaipur, Rajasthan, India
Dr. Vineet's Clinic
🇮🇳New Delhi, Uttar Pradesh, India
Galaxy Care Laproscopic Institute
🇮🇳Pune, Maharashtra, India
Annapurna Medical and Cancer Relief Society
🇮🇳Lucknow, Uttar Pradesh, India
SMS Hospital
🇮🇳Jaipur, Rajasthan, India
B.R. Singh Hospital
🇮🇳Kolkatta, West Bengal, India
Swarna Sai Hospital
🇮🇳Secunderabad, Andhra Pradesh, India
All India Institute of Medical Sciences
🇮🇳New Delhi, Delhi, India
Wellness Consultants Clinic
🇮🇳Surat, Gujarat, India
S M Karandikar's Clinic
🇮🇳Pune, Maharashtra, India
NVS Ramakrishna's Clinic
🇮🇳Hyderabad, Andhra Pradesh, India
Dr. T. P. Sahoo's Clinic
🇮🇳Bhopal, Madhya Pradesh, India
Neigrihms
🇮🇳Shillong, Meghalaya, India
J.K.Cancer Institute
🇮🇳Kanpur, Uttar Pradesh, India
Indo- American Cancer Institute & Research Centre
🇮🇳Hyderabad, Andhra Pradesh, India
Dr. Nikhil's Clinic
🇮🇳Secunderabad, Andhra Pradesh, India
Global Health Pvt Ltd
🇮🇳Gurgaon, Haryana, India
BND Onco Centre
🇮🇳Mumbai, Maharashtra, India
S.L.Raheja Hospital
🇮🇳Mumbai, Maharashtra, India
Ambaa Hospitals
🇮🇳Hyderabad, Andhra Pradesh, India
Sparsh Hospital
🇮🇳Orissa, Bhubaneswar, India
The Cancer Clinic
🇮🇳Kochin, Kerala, India
Grace Nursing Home
🇮🇳Aizwal, Mizoram, India
Cancer Clinic
🇮🇳Jaipur, Rajasthan, India
SMH-Curie Cancer Centre, Shanti Mukand Hospital
🇮🇳New Delhi, Uttar Pradesh, India
Sunil Gupta's Clinic
🇮🇳Delhi, India
Apollo Gleneagles Cancer Hospital
🇮🇳Kolkata, West Bengal, India
Ruby Hall Clinic
🇮🇳Pune, Maharashtra, India