patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx newly diagnosed and eligible for surgery. MedDRA version: 9.1 Level: LLT Classification code 10041857 Term: Squamous cell carcinoma of the oral cavity MedDRA version: 9.1 Level: LLT Classification code 10031112 Term: Oropharyngeal squamous cell carcinoma MedDRA version: 9.1 Level: LLT Classification code 10021042 Term: Hypopharyngeal cancer MedDRA version: 9.1 Level: LLT Classification code 10023856
Conditions
Interventions
Trade Name: erbitux
Pharmaceutical Form: Intravenous infusion
Sponsors
Cliniques Universitaires St Luc, Centre du Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age 18 years and over •Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx •Patients selected for a primary surgical treatment •No distant metastases •No contraindications to cetuximab • No active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix •No prior or concurrent evidence of uncontrolled severe pathology precluding administration of surgery (i.e. unstable cardiopathy,…) •Life expectancy of 3 months •Not pregnant or nursing: fertile patients must use effective contraception •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial •Signed informed consent. •Performance status ECOG 0-1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Nasopharynx cancer •Past or current malignancy other than HNSCC, except for: •Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol •Neutrophils count = 1,500/mm3, platelet count = 75,000/mm3, WBC 2 times ULN, ALAT or ALAP > 5 times ULN. •Use of any investigational agent(s) within 4 weeks prior to entry •Previous exposure to EGFR targeting therapy •Known grade 3 or 4 allergic reaction to any of the components of the treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety of neoadjuvant administration of cetuximab in patients with operable head and neck cancer -Phase I part: To determine the safe minimum delay between preoperative cetuximab infusion and surgery (Target delay between cetuximab and surgery = 24 hours) -Phase II part: To investigate the safety of the minimum delay determined in the phase I part ;Secondary Objective: - To investigate the safety of postoperative radiation therapy in combination with cetuximab in patients eligible for postoperative radiation therapy alone after surgery - To investigate the efficacy of cetuximab monotherapy in the pre-operative setting, using FDG-PET and PET/CT scan - To perform translational research ;Primary end point(s): To investigate the safety of neoadjuvant administration of cetuximab in patients with operable head and neck cancer •Phase I part: To determine the safe minimum delay between preoperative cetuximab infusion and surgery (Target delay between cetuximab and surgery = 24 hours) •Phase II part: To investigate the safety of the minimum delay determined in the phase I part | — |
Countries
Belgium
Outcome results
None listed