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 (PMS LAD SCCHN)

This study has been terminated.
(The study was discontinued due to slow recruitment and subjects not completing follow up period.)
Sponsor:
Collaborator:
Merck Ltd., India
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01303237
First received: February 23, 2011
Last updated: November 7, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Unresectable Locally Advanced Squamous Cell Carcinoma of Head and Neck
LA SCCHN
Drug: Cetuximab + RT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Number of Patients with Serious Adverse Reactions [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.


Secondary Outcome Measures:
  • Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Duration of Locoregional Disease Control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: 8 weeks (Post completion of treatment duration) ] [ Designated as safety issue: No ]
  • Management of skin conditions due to treatment protocol [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: February 2011
Estimated Study Completion Date: March 2018
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab + RT
    Cetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT
    Other Name: Erbitux
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303237

Locations
India
Omega Hospital
Hyderabad, Andhra Pradesh, India, 500034
Shanti Chandra Family Clinic
Hyderabad, Andhra Pradesh, India, 500034
Swarna Sai Hospital
Hyderabad, Andhra Pradesh, India, 500059
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, India, 500025
Arogya Multispeciality Clinic
Mangalore, Bangalore, India, 575002
Aastha Oncology Associates
Ahmedabad, Gujarat, India, 380006
Navneet Memorial Centre
Ahmedabad, Gujarat, India, 380006
Meharbai TATA Memorial Hospital
Bistupur, Jamshedpur, India, 831001
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, India, 462001
Dr S M Karandikar Hospital
Pune, Maharashtra, India, 411004
Dwidal Nursing Home
Pune, Maharashtra, India, 411004
Ruby Hall Clinic
Pune, Maharashtra, India, 411001
Regional cancer center
Sheikpura, Patna, India, 800014
Grecian Superspeciality Hospital
Mohali, Punjab, India, 160055
Harmony Health Care
Mohali, Punjab, India, 160062
Balaji Clinic & General Hospital
Jaipur, Rajasthan, India, 302018
Bhagwan Mahaveer Cancer Hospital & Research Center
Jaipur, Rajasthan, India, 3020 17
Cancer Care Centre
Jaipur, Rajasthan, India, 302017
SMS Hospital
Jaipur, Rajasthan, India, 302004
Royal Cancer Institute and Research Centre
Kanpur, Uttar Pradesh, India, 208002
SMH Curie Cancer Centre
New Delhi, Uttar Pradesh, India, 201010
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, India, 700054
Bengal Oncology
Kolkata, West Bengal, India, 700031
Oncologist & Palliative Care Specialist Clinic
Kolkata, West Bengal, India, 700064
Dr. Meenu's Clinic
Delhi, India, 201301
Sponsors and Collaborators
Merck KGaA
Merck Ltd., India
Investigators
Study Director: Rajiv Rana, MD Merck Ltd., India
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01303237     History of Changes
Other Study ID Numbers: EMR062202-539
Study First Received: February 23, 2011
Last Updated: November 7, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Merck KGaA:
LA SCCHN
Cetuximab
RT
PMS

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 25, 2015