LA SCCHN Clinical Trial
— PMS LAD SCCHNOfficial 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)
| Verified date | June 2017 |
| Source | Merck KGaA |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 88 |
| Est. completion date | August 5, 2014 |
| Est. primary completion date | June 30, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - 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: - Exclusion criteria as per the product label for LA SCCHN approved by India Health Authority |
| Country | Name | City | State |
|---|---|---|---|
| India | Aastha Oncology Associates | Ahmedabad | Gujarat |
| India | Navneet Memorial Centre | Ahmedabad | Gujarat |
| India | Dr. T. P. Sahoo's Clinic | Bhopal | Madhya Pradesh |
| India | Meharbai TATA Memorial Hospital | Bistupur | Jamshedpur |
| India | Dr. Meenu's Clinic | Delhi | |
| India | Omega Hospital | Hyderabad | Andhra Pradesh |
| India | Shanti Chandra Family Clinic | Hyderabad | Andhra Pradesh |
| India | Swarna Sai Hospital | Hyderabad | Andhra Pradesh |
| India | Balaji Clinic & General Hospital | Jaipur | Rajasthan |
| India | Bhagwan Mahaveer Cancer Hospital & Research Center | Jaipur | Rajasthan |
| India | Cancer Care Centre | Jaipur | Rajasthan |
| India | SMS Hospital | Jaipur | Rajasthan |
| India | Royal Cancer Institute and Research Centre | Kanpur | Uttar Pradesh |
| India | Apollo Gleneagles Cancer Hospital | Kolkata | West Bengal |
| India | Bengal Oncology | Kolkata | West Bengal |
| India | Oncologist & Palliative Care Specialist Clinic | Kolkata | West Bengal |
| India | Arogya Multispeciality Clinic | Mangalore | Bangalore |
| India | Grecian Superspeciality Hospital | Mohali | Punjab |
| India | Harmony Health Care | Mohali | Punjab |
| India | SMH Curie Cancer Centre | New Delhi | Uttar Pradesh |
| India | Dr S M Karandikar Hospital | Pune | Maharashtra |
| India | Dwidal Nursing Home | Pune | Maharashtra |
| India | Ruby Hall Clinic | Pune | Maharashtra |
| India | Dr. Nikhil's Clinic | Secunderabad | Andhra Pradesh |
| India | Regional cancer center | Sheikpura | Patna |
| Lead Sponsor | Collaborator |
|---|---|
| Merck KGaA | Merck Ltd., India |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Response Rate | 3 years | ||
| Secondary | Progression Free Survival | 3 years | ||
| Secondary | Duration of Locoregional Disease Control | 3 years | ||
| Secondary | Overall Survival | 3 years | ||
| Secondary | Response Rate | 8 weeks (Post completion of treatment duration) | ||
| Secondary | Management of skin conditions due to treatment protocol | 3 years |