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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck KGaA, Darmstadt, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Ltd., India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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