Head and Neck Cancer Clinical Trial
— CHIRONOfficial title:
Neoadjuvant Cetuximab Monotherapy Followed by Surgery in Squamous Cell Carcinoma of Head and Neck: Phase I/II Study
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 time elapsing between last infusion and surgery.
Iterative biomarkers will be taken at 6 time points permitting to investigate expression gen
profile and protein mutation.
Status | Completed |
Enrollment | 34 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires St Luc-UCL | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Merck Serono International SA, Merck Sharp & Dohme Corp. |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To investigate the safety administration of cetuximab - Phase 1: to determine the safe minimum delay between preoperative cetuximab infusion and surgery -Phase II: to investigate the safety of the minimum delay determined in the phase I part. | 10 weeks | Yes | |
Secondary | To investigate the safety of postoperative radiation therapy in combination with cetuximab | 10 weeks | Yes | |
Secondary | To investigate the efficacy of cetuximab monotherapy in the pre-operative setting, using FDG-PET and PET/CT scan. | 10 weeks | Yes | |
Secondary | To perform translational research | 10 weeks | Yes |
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