Open, uncontrolled, non-commercial Clinical Trial of induction chemotherapy with Cetuximab, Docetaxel, Cisplatin, 5FU followed by Cetuximab + radiotherapy in the responders in locally advanced resectable SCCH

• Conditions: locally advanced squamous cell carcinoma of head and neck (SCCHN); MedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2007-002782-12-HU
• Lead Sponsor: ational Institute of Oncology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Signed written informed consent
- Male or female >18 years of age
- Newly diagnosed, histologically confirmed squamous cell carcinoma of the oral cavity,oropharynx, hypopharynx or larynx; locally advanced, resectable disease
- Presence of at least one bidimensionally measurable index lesion
- Declaration of two independent head and neck surgeons in the context of a multidisciplinary tumor conference on the operability of the patient, and description of planned type of surgery in case if the patient will be non-responder
- Written declaration of the patient, that he/she prefers primary non surgical treatment after detailed information concerning both treatment modalities, procedures and consequences
- Karnofsky Performance Status = 80 at study entry
- Effective contraception for both male and female subjects if risk of conception exists
- Bilirubin level = 1.5 x ULN
- AST and/or ALT = 2.5 x ULN
- Serum creatinine =1.5 x ULN
- Leukocytes count = 3 x 109/L, neutrophils = 1.5 x109/L, platelets > 100 x 109/L, and hemoglobin > 9 g/dL

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

- Metastatic disease
- Any kind of previous therapy for SCCHN (excluding diagnostic biopsy)
- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy which is not part of the study protocol
- Participation in another clinical trial within 30 days prior to study entry
- Previous administration of EGFR pathway-targeting therapy
- Clinically relevant coronary artery disease, history of myocardial infarction within the last 6 months, or high risk/uncontrolled arrhythmia
- Known grade 3 or 4 allergic reaction to any of the components of the treatment
- Pregnancy (absence confirmed by serum/urine HCG in premenopausal women) or breast-feeding
- History of severe pulmonary disease
- Any investigational agents within the past 30 days
- Having previously participated in a study which included the possibility of being allocated to cetuximab therapy (whether or not the subject actually received cetuximab)
- Other previous malignancies within 5 years, with exception of a history of adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Known drug abuse
- Legal incapacity or limited legal capacity
- Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of induction chemotherapy with Cetuximab+Docetaxel+Cisplatin +5-FU followed by Cetuximab + radiotherapy in the responders in SCCHN patients.<br>Rate of complete clinical response (imaging and physical examination) <br>will be assessed at 3 months after the end of treatment<br>;Secondary Objective: - safety and toxicity of the combination of cetuximab and chemotherapy with docetaxel+cisplatin+fluorouracil (TPF), <br>- safety and toxicity of the combination of cetuximab and radiotherapy<br>- response rate after induction chemotherapy,<br>- SUV changes of tumour measured by PET scan at baseline and at the end of study (optional measurement)<br>;Primary end point(s): Primary endpoint of the study is defined as the ratio of the number of patients with complete response (CR) at the 25th week, and the number of the patients who receive further cetuximab therapy at the 6th week.