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The study was discontinued due to slow recruitment and subjects not completing follow up period.
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| Name | Class |
|---|---|
| Merck Ltd., India | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab + RT | Drug | Cetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Serious Adverse Reactions | Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | 3 years | |
| Progression Free Survival | 3 years | |
| Duration of Locoregional Disease Control |
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Inclusion Criteria:
Exclusion Criteria:
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Unresectable Locally Advanced (Stage III/ IV A or IV B) SCCHN patients found eligible to receive Cetuximab + RT
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| Name | Affiliation | Role |
|---|---|---|
| Rajiv Rana, MD | Merck Ltd., India | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omega Hospital | Hyderabad | Andhra Pradesh | 500034 | India | ||
| Shanti Chandra Family Clinic |
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| 3 years |
| Overall Survival | 3 years |
| Response Rate | 8 weeks (Post completion of treatment duration) |
| Management of skin conditions due to treatment protocol | 3 years |
| Hyderabad |
| Andhra Pradesh |
| 500034 |
| India |
| Swarna Sai Hospital | Hyderabad | Andhra Pradesh | 500059 | India |
| Dr. Nikhil's Clinic | Secunderabad | Andhra Pradesh | 500025 | India |
| Arogya Multispeciality Clinic | Mangalore | Bangalore | 575002 | India |
| Aastha Oncology Associates | Ahmedabad | Gujarat | 380006 | India |
| Navneet Memorial Centre | Ahmedabad | Gujarat | 380006 | India |
| Meharbai TATA Memorial Hospital | Bistupur | Jamshedpur | 831001 | India |
| Dr. T. P. Sahoo's Clinic | Bhopal | Madhya Pradesh | 462001 | India |
| Ruby Hall Clinic | Pune | Maharashtra | 411001 | India |
| Dr S M Karandikar Hospital | Pune | Maharashtra | 411004 | India |
| Dwidal Nursing Home | Pune | Maharashtra | 411004 | India |
| Regional cancer center | Sheikpura | Patna | 800014 | India |
| Grecian Superspeciality Hospital | Mohali | Punjab | 160055 | India |
| Harmony Health Care | Mohali | Punjab | 160062 | India |
| Bhagwan Mahaveer Cancer Hospital & Research Center | Jaipur | Rajasthan | 3020 17 | India |
| SMS Hospital | Jaipur | Rajasthan | 302004 | India |
| Cancer Care Centre | Jaipur | Rajasthan | 302017 | India |
| Balaji Clinic & General Hospital | Jaipur | Rajasthan | 302018 | India |
| Royal Cancer Institute and Research Centre | Kanpur | Uttar Pradesh | 208002 | India |
| SMH Curie Cancer Centre | New Delhi | Uttar Pradesh | 201010 | India |
| Bengal Oncology | Kolkata | West Bengal | 700031 | India |
| Apollo Gleneagles Cancer Hospital | Kolkata | West Bengal | 700054 | India |
| Oncologist & Palliative Care Specialist Clinic | Kolkata | West Bengal | 700064 | India |
| Dr. Meenu's Clinic | Delhi | 201301 | India |
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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