Status:
COMPLETED
Cetuximab (Erbitux) 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 (EXTREME)
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT00122460
Start Date
December 1 2004
End Date
January 1 2011
Last Update
July 23 2014
Active Locations (70)
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1
Research Site
Innsbruck, Austria
2
Research Site
Vienna, Austria
3
Research Site
Brussels, Belgium
4
Research Site
Edegem, Belgium