Studie BO18255 - Magenkarzinom
Eine offene, randomisierte, multizentrische Phase-III-Studie mit Trastuzumab in Kombination mit einem Fluoropyrimidin und Cisplatin versus Chemotherapie allein als First-line-Therapie bei Patienten mit HER2-positivem, fortgeschrittenem Magenkarzinom.
Rekrutierung
Die Studie rekrutiert aktuell Patienten.Studiendesign
randomisiert, multizentrisch, Phase IIIStudienziel
Primary outcome: Efficacy: Overall survival. Key secondary outcomes: Efficacy: Progression-free survival, overall response rate, clinical benefit rate, duration of response Safety: AEs, laboratory tests, vital signs, LVEF, creatinine clearanceSynopsis
This study will evaluate the efficacy, safety, pharmacokinetics and effect on quality of life of intravenous Herceptin in combination with 2 different regimens of 2 chemotherapy agents, compared with these chemotherapy regimens alone, in patients with HER2-positive advanced gastric cancer. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.Einschlusskriterien
- adult patients (≥18 years of age)
- inoperable locally advanced, recurrent, or metastatic cancer of the stomach or gastro-esophageal junction
- adenocarcinoma
- HER2-positive tumors
Ausschlusskriterien
- previous chemotherapy for advanced/metastatic disease
- lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
- history of cardiac disease
- dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy
Studienassistentin
Frau Gröger, Telefon: 06131 17-5543Studienleiter
Herr Dr. habil. Markus MöhlerWeitere Informationen