Study of the combination of gemcitabine, cetuximab and radiotherapy in patients with head and neck cancer - RAGE
- Conditions
- Histologically confirmed squamous cell carcinoma of the head and neck which qualifies for definitive treatment with chemoradiationMedDRA version: 12.1Level: LLTClassification code 10067821Term: Head and neck cancer
- Registration Number
- EUCTR2009-017943-32-BE
- Lead Sponsor
- Antwerp University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 25
Written and signed informed consent
Histologically confirmed squamous cell carcinoma of the head and neck which qualifies for definitive treatment with chemoradiation
Life expectancy of at least 12 weeks
Age > 18 years
Performance status of 0 or 1 according to the World Health Organization (WHO)
Adequate hematologic, cardiac, pulmonary, renal and liver function
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
Pregnant or lactating women or women of childbearing potential without adequate contraceptive measures.
Known brain or leptomeningeal metastasis
Other serious medical conditions
Congestive heart failure, uncontrolled angina pectoris, uncontrolled hypertension or uncontrolled arrhythmia
Active infection
History of significant neurologic or psychiatric disorders
Known hypersensitivity reactions to cetuximab or gemcitabine or one of the excipients.
Altered fractionation radiotherapy.
Prior radiotherapy and/or chemotherapy (except as induction chemotherapy) within 6 months before enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method