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 III

Studienziel

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 clearance

Synopsis

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 17-5543

Studienleiter

Herr Dr. habil. Markus Möhler
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