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Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the
head and neck (SCCHN)

- Recurrent and/or metastatic SCCHN, not suitable for local therapy

Exclusion Criteria:

- Prior systemic chemotherapy, except if given as part of a multimodal treatment for
locally advanced disease which was completed more than 6 months prior to study entry

- Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before
study entry

- Nasopharyngeal carcinoma

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival Time (OS)

Outcome Description:

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

Outcome Time Frame:

time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007

Safety Issue:

No

Principal Investigator

Jan B. Vermorken, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Antwerpen, Department of Medical Oncology, 2650-Edegem, Belgium

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

EMR 62202-002

NCT ID:

NCT00122460

Start Date:

December 2004

Completion Date:

July 2011

Related Keywords:

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

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