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An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)


N/A
N/A
N/A
Open (Enrolling)
Both
Carcinoma, Squamous Cell

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Trial Information

An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)


Inclusion Criteria:



- The study inclusion criteria is as per the label for patients with
metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is
indicated for the treatment of patients with squamous cell cancer of the head and
neck in combination with platinum-based chemotherapy for recurrent and/or metastatic
disease."

- For each platinum-based chemotherapy, the related product labels approved by India
Health Authorities will also be followed strictly in terms of patient eligibility.

Exclusion Criteria:

- Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity
Criteria [NCI-CTC]) hypersensitivity reactions to Cetuximab are contraindicated for
Cetuximab

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.

Outcome Description:

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)

Outcome Time Frame:

From first infusion of cetuximab until 28 days after the last infusion.

Safety Issue:

Yes

Principal Investigator

Dr. Rajiv Rana

Investigator Role:

Study Director

Investigator Affiliation:

Merck Ltd., India

Authority:

India: Ministry of Health

Study ID:

EMR 062202-514

NCT ID:

NCT01142869

Start Date:

December 2009

Completion Date:

April 2016

Related Keywords:

  • Carcinoma, Squamous Cell
  • Carcinoma, Squamous Cell
  • Erbitux
  • Neoplasms, Squamous Cell
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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