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 is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Merck KGaA
Sponsor:
Collaborator:
Merck Ltd., India
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01303237
First received: February 23, 2011
Last updated: June 12, 2012
Last verified: June 2012
  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 ]

Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Primary Completion Date: May 2016 (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

Contacts
Contact: Rajiv Rana, Dr. +91 22 66609000

Locations
India
Omega Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Dr.Palanki Dattatreya    9440591396    satya_palanki@rediffmail.com   
Shanti Chandra Family Clinic Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Dr. Siva Kumar    9848255843 or 9346224574    siva_k@rediffmail.com   
Omega Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Dr.S S Nirni    9849062003    nirni2002@rediffmail.com   
Omega Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Dr. Sankar Mahadev    9848050717    drdoala@hotmail.com   
Swarna Sai Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500059
Contact: Dr. C. Sairam    9849032198    brcsairam@hotmail.com   
Dr. Nikhil's Clinic Recruiting
Secunderabad, Andhra Pradesh, India, 500025
Contact: Dr. Nikhil Ghadyalpatil    8008037474    nikhilghadyalpatil@gmail.com   
Arogya Multispeciality Clinic Recruiting
Mangalore, Bangalore, India, 575002
Contact: Dr. Suresh Rao    9886904088    raos_64@yahoo.com   
Aastha Oncology Associates Recruiting
Ahmedabad, Gujarat, India, 380006
Contact: Dr. Vivek Bansal    9909215300    vbhinduja@yahoo.com   
Navneet Memorial Centre Recruiting
Ahmedabad, Gujarat, India, 380006
Contact: Dr. Devang Bhavsar    9825374411    dr_bhavsar@hotmail.com   
Meharbai TATA Memorial Hospital Recruiting
Bistupur, Jamshedpur, India, 831001
Contact: Dr. Amit Kumar    9534538078    docamit.kumar@gmail.com   
Dr. T. P. Sahoo's Clinic Recruiting
Bhopal, Madhya Pradesh, India, 462001
Contact: Dr. Tarini P Sahoo    9893686246    tarini73@rediffmail.com   
Dr S M Karandikar Hospital Recruiting
Pune, Maharashtra, India, 411004
Contact: Dr. S. M. Karandikar    9890281963    skaran44@gmail.com   
Dwidal Nursing Home Recruiting
Pune, Maharashtra, India, 411004
Contact: Dr. K. P. Bokil    9822051743    kamleshbokil@hotmail.com   
Ruby Hall Clinic Recruiting
Pune, Maharashtra, India, 411001
Contact: Dr. Minish Jain    9823133390    minishjain009@gmail.com   
Regional cancer center Recruiting
Sheikpura, Patna, India, 800014
Contact: Dr. Rajiv Ranjan    9431016862    drmrr@yahoo.com   
Harmony Health Care Recruiting
Mohali, Punjab, India, 160062
Contact: Dr. K. K. Naik    9878062123    drkknaik@gmail.com   
Grecian Superspeciality Hospital Recruiting
Mohali, Punjab, India, 160055
Contact: Dr. Vinod Nimbran    9814426764    vknimbran@rediffmail.com   
Cancer Care Centre Recruiting
Jaipur, Rajasthan, India, 302017
Contact: Dr. Nidhi Patni    9828052239    patni.nidhi@gmail.com   
Balaji Clinic & General Hospital Recruiting
Jaipur, Rajasthan, India, 302018
Contact: Dr. O. P. Sharma    9829057033    dropsharma@yahoo.co.in   
SMS Hospital Recruiting
Jaipur, Rajasthan, India, 302004
Contact: Dr. D. P. Singh    094142-63400    drdpsingh@yahoo.com   
Bhagwan Mahaveer Cancer Hospital & Research Center Recruiting
Jaipur, Rajasthan, India, 3020 17
Contact: Dr. Naresh Somani    0141-2700107    drsomani@somexresearch.com   
Royal Cancer Institute and Research Centre Recruiting
Kanpur, Uttar Pradesh, India, 208002
Contact: Dr. Anu Tiwari    9450093066    anu412@rediffmail.com   
SMH Curie Cancer Centre Recruiting
New Delhi, Uttar Pradesh, India, 201010
Contact: Dr. Munish Gairola    9958431598    gairolam@hotmail.com   
Bengal Oncology Active, not recruiting
Kolkata, West Bengal, India, 700031
Apollo Gleneagles Cancer Hospital Recruiting
Kolkata, West Bengal, India, 700054
Contact: Dr. P. N. Mohapatra    9674311610    prabrajya.mohapatra@rediffmail.com   
Oncologist & Palliative Care Specialist Clinic Recruiting
Kolkata, West Bengal, India, 700064
Contact: Dr. Arundhati Chakraborty    9831742166    arundhatic@rediffmail.com   
Dr. Meenu's Clinic Recruiting
Delhi, India, 201301
Contact: Dr. Meenu Wallia    9818994001    drmeenuwalia@dhrc.in   
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: June 12, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by Merck KGaA:
LA SCCHN
Cetuximab
RT
PMS

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

ClinicalTrials.gov processed this record on July 26, 2014