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A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)

18 Years
Open (Enrolling)
Carcinoma, Squamous Cell of Head and Neck

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Trial Information

A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)

Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of
some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping
toxicities with these approaches. This prospective, observational, non-interventional and
multi-centric post marketing surveillance study is being conducted to collect safety
information from subjects with locally advanced or recurrent/metastatic SCCHN treated with
cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects,
who are eligible for cetuximab treatment according to the indication in the approved label
of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant
tumor history, and laboratory information (hematology, biochemistry) will be captured and
analyzed descriptively.


Primary objective:

• To obtain safety information on the use of cetuximab in subjects with SCCHN according to
the regulatory approved label and in a regular clinical setting

Secondary objectives:

• To gather clinical efficacy information of the treatment

Inclusion Criteria:

- Histologically proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx,
larynx) or recurrent and/or metastatic SCCHN

- Age greater than or equal to 18 years

- Signed informed consent

Exclusion Criteria:

- Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity
Criteria Version 4.03) hypersensitivity reactions to Cetuximab

- Subjects with contraindications for concomitantly used chemotherapeutic agents or
radiation therapy, identified before initiation of cetuximab combination treatment

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of adverse drug reactions and serious adverse drug reactions

Outcome Time Frame:

From the first infusion of cetuximab until three months after the last infusion of Cetuximab

Safety Issue:


Principal Investigator

Chao-Jung Tsao, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Liouying Chi-Mei Hospital


Taiwan: Department of Health

Study ID:




Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Carcinoma, Squamous Cell of Head and Neck
  • Carcinoma
  • Squamous cell
  • Erbitux
  • cetuximab
  • Head
  • Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms