Clinical trial NCT01303237: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
LA SCCHN
Keywords: LA SCCHN
Cetuximab
RT
PMS
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Ltd., India
First posted: 2011-02-24
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unresectable Locally Advanced (Stage III/ IV A or IV B) SCCHN patients found eligible to receive Cetuximab + RT

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 criteria: 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

Primary outcomes:
measure: Number of Patients with Serious Adverse Reactions
timeFrame: 3 years
Secondary outcomes:
measure: Response Rate
timeFrame: 3 years
measure: Progression Free Survival
timeFrame: 3 years
measure: Duration of Locoregional Disease Control
timeFrame: 3 years
measure: Overall Survival
timeFrame: 3 years
measure: Response Rate
timeFrame: 8 weeks (Post completion of treatment duration)
measure: Management of skin conditions due to treatment protocol
timeFrame: 3 years
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Omega Hospital
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Shanti Chandra Family Clinic
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Swarna Sai Hospital
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Dr. Nikhil's Clinic
state: Andhra Pradesh
city: Mangalore
country: India
facility: Arogya Multispeciality Clinic
state: Bangalore
city: Ahmedabad
country: India
facility: Aastha Oncology Associates
state: Gujarat
city: Ahmedabad
country: India
facility: Navneet Memorial Centre
state: Gujarat
city: Bistupur
country: India
facility: Meharbai TATA Memorial Hospital
state: Jamshedpur
city: Bhopal
country: India
facility: Dr. T. P. Sahoo's Clinic
state: Madhya Pradesh
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharashtra
city: Pune
country: India
facility: Dr S M Karandikar Hospital
state: Maharashtra
city: Pune
country: India
facility: Dwidal Nursing Home
state: Maharashtra
city: Sheikpura
country: India
facility: Regional cancer center
state: Patna
city: Mohali
country: India
facility: Grecian Superspeciality Hospital
state: Punjab
city: Mohali
country: India
facility: Harmony Health Care
state: Punjab
city: Jaipur
country: India
facility: Bhagwan Mahaveer Cancer Hospital & Research Center
state: Rajasthan
city: Jaipur
country: India
facility: SMS Hospital
state: Rajasthan
city: Jaipur
country: India
facility: Cancer Care Centre
state: Rajasthan
city: Jaipur
country: India
facility: Balaji Clinic & General Hospital
state: Rajasthan
city: Kanpur
country: India
facility: Royal Cancer Institute and Research Centre
state: Uttar Pradesh
city: New Delhi
country: India
facility: SMH Curie Cancer Centre
state: Uttar Pradesh
city: Kolkata
country: India
facility: Bengal Oncology
state: West Bengal
city: Kolkata
country: India
facility: Apollo Gleneagles Cancer Hospital
state: West Bengal
city: Kolkata
country: India
facility: Oncologist & Palliative Care Specialist Clinic
state: West Bengal
city: Delhi
country: India
facility: Dr. Meenu's Clinic
Study officials:
affiliation: Merck Ltd., India
name: Rajiv Rana, MD
role: STUDY_DIRECTOR
References: