Status:
COMPLETED
Neoadjuvant Cetuximab in HNSCC Combined With Curative Surgery
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Merck Serono International SA
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Primary diagnose HNSCC carcinoma patients eligible for curative surgery will be proposed the addition of 2 or 3 neoadjuvant cetuximab infusions. The main objective is to reduce to a minimal delay the ...
Detailed Description
This is a Phase I/II trial of neoadjuvant cetuximab monotherapy in the preoperative treatment of patients with operable HNSCC. It is a monocenter study (St-Luc university Hospital, Université catholiq...
Eligibility Criteria
Inclusion
- More than 18 years
- Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- patients selected for a primary surgical treatment
- No distant metastases
- No active second malignancy during the last 5 years
- No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery
- life expectancy more than 3 months
- Not pregnant or nursing; fertile patients both male or female, must use effective contraception
- Signed informed consent
- Performance Status ECOG 0-1
Exclusion
- Nasopharynx cancer
- Past or current malignancy other than HNSCC
- performance Status ECOG above 2
- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
- Use of any investigationals agents within 4 weeks prior ti entry
- Previous exposure to EGFR targeting therapy
- Known grade hypersensitivity to cetuximab
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00714649
Start Date
July 1 2008
End Date
May 1 2011
Last Update
November 14 2012
Active Locations (1)
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1
Cliniques Universitaires St Luc-UCL
Brussels, Belgium, 1200