Efficacy of the EGFR antibody Cetuximab in combination with weekly Oxaliplatin/5FU/Folinsäure (AIO-FUFOX) in advanced gastro-oesophageal adenocarcinoma - STOMOX II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004024-12-DE

Enrollment

Registered

2005-02-17

Start date

2005-04-05

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced gastro-oesophageal adenocarcinoma

Interventions

Trade Name: Erbitux Product Name: Erbitux Product Code: EMD271786 Pharmaceutical Form: Intravenous infusion Trade Name: Eloxatin Product Name: Eloxatin Pharmaceutical Form: Intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Second malignancy Cardiac insufficiency, untreated ischemic heart disease Uncontrolled Infection Uncontrolled diabetes mellitus

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Austria, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026