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)

June 8, 2017 updated by: Merck KGaA, Darmstadt, Germany

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Serious Adverse Reactions
Time Frame: 3 years
Number of patients with Serious Adverse Reactions will be assessed to discover the tolerability of the treatment regimen.
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 3 years
3 years
Response Rate
Time Frame: 3 years
3 years
Progression Free Survival
Time Frame: 3 years
3 years
Duration of Locoregional Disease Control
Time Frame: 3 years
3 years
Response Rate
Time Frame: 8 weeks (Post completion of treatment duration)
8 weeks (Post completion of treatment duration)
Management of skin conditions due to treatment protocol
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Ltd., India

Investigators

  • Study Director: Rajiv Rana, MD, Merck Ltd., India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2011

Primary Completion (Actual)

June 30, 2013

Study Completion (Actual)

August 5, 2014

Study Registration Dates

First Submitted

February 23, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR062202-539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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