Study Stopped
The study was discontinued due to slow recruitment and subjects not completing follow up period.
An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy in the First-line Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
1 other identifier
observational
133
1 country
28
Brief Summary
The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2009
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2009
CompletedFirst Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 5, 2014
CompletedMay 8, 2017
May 1, 2017
3.6 years
June 10, 2010
May 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
Safety variables will include the assessment of incidence and type of adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), incidence of withdrawals due to intolerability of cetuximab and severity of adverse events (AEs)
From first infusion of cetuximab until 28 days after the last infusion.
Secondary Outcomes (1)
To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.
From first infusion of cetuximab until 28 days after the last infusion.
Interventions
The starting dose will be intravenous (IV) cetuximab 400 mg/m2 body surface area administered as a 120-minute infusion once a week . The subsequent weekly doses will be IV cetuximab 250 mg/m2 administered as a 60-minute infusion. The maximum infusion rate must not exceed 10 mg/min.
Eligibility Criteria
Patients with squamous cell carcinoma of head and neck
You may qualify if:
- For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.
You may not qualify if:
- Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria \[NCI-CTC\]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck KGaA, Darmstadt, Germanylead
- Merck Ltd., Indiacollaborator
Study Sites (28)
Ambaa Hospitals
Hyderabad, Andhra Pradesh, 500008, India
Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, 500034, India
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, 500063, India
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, 500025, India
Swarna Sai Hospital
Secunderabad, Andhra Pradesh, 500059, India
Sparsh Hospital
Orissa, Bhubaneswar, 751007, India
Wellness Consultants Clinic
Surat, Gujarat, 395002, India
Global Health Pvt Ltd
Gurgaon, Haryana, 122001, India
The Cancer Clinic
Kochi, Kerala, 682304, India
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, 462001, India
BND Onco Centre
Mumbai, Maharashtra, 400014, India
S.L.Raheja Hospital
Mumbai, Maharashtra, 400016, India
S M Karandikar's Clinic
Pune, Maharashtra, 400014, India
Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Galaxy Care Laproscopic Institute
Pune, Maharashtra, 411004, India
Neigrihms
Shillong, Meghālaya, 793005, India
Grace Nursing Home
Aizawl, Mizoram, 796 009, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Cancer Clinic
Jaipur, Rajasthan, 302004, India
SMS Hospital
Jaipur, Rajasthan, 302004, India
Bhagwan Mahaveer Cancer Hospital
Jaipur, Rajasthan, 302006, India
J.K.Cancer Institute
Kanpur, Uttar Pradesh, 208002, India
Annapurna Medical and Cancer Relief Society
Lucknow, Uttar Pradesh, 226007, India
Dr. Vineet's Clinic
New Delhi, Uttar Pradesh, 110085, India
SMH-Curie Cancer Centre, Shanti Mukand Hospital
New Delhi, Uttar Pradesh, 110092, India
B.R. Singh Hospital
Kolkata, West Bengal, 700014, India
Apollo Gleneagles Cancer Hospital
Kolkata, West Bengal, 700054, India
Sunil Gupta's Clinic
Delhi, 110092, India
Biospecimen
Whole Blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Rajiv Rana
Merck Ltd., India
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 11, 2010
Study Start
December 31, 2009
Primary Completion
July 31, 2013
Study Completion
August 5, 2014
Last Updated
May 8, 2017
Record last verified: 2017-05