Efficacy of the EGFR antibody Cetuximab in combination with weekly Oxaliplatin/5FU/Folinsäure (AIO-FUFOX) in advanced gastro-oesophageal adenocarcinoma - STOMOX II
Phase 1
- Conditions
- advanced gastro-oesophageal adenocarcinoma
- Registration Number
- EUCTR2004-004024-12-DE
- Lead Sponsor
- Technical University of Munich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
histologically confirmed gastro-oesophageal adenocarcinoma
advanced disease (locally irresectable or metatstatic)
no systemic pretreatment, one neoadjuvant or adjuvant chemotherapy is acceptable (>6 month)
at least one unidimensional measurable cancer manifestation (>/= 1cm)
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
Second malignancy
Cardiac insufficiency, untreated ischemic heart disease
Uncontrolled Infection
Uncontrolled diabetes mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of the combination of Oxaliplatin/5-fluorouracil/folinic acid plus cetuximab in advanced adenocarcinoma of the esophagus and stomach. Primary endpoint is the objectice reponse rate;Secondary Objective: Toxicity, progression free survival, time to progression, overall survival, duration of response, response rate in immunihistochemically EGFR-negativ gastric cancer;Primary end point(s): Objective response rate according to RECIST
- Secondary Outcome Measures
Name Time Method