OPPOSITE: Outcome Prediction of Systemic Treatment in Esophagogastric Carcinoma

Launched by UNIVERSITY HOSPITAL HEIDELBERG · Feb 5, 2018

Keywords

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Eligibility criteria

• Inclusion Criteria:
• Histologically confirmed, resectable adenocarcinoma of the GEJ (type I-III) or the stomach (cT2, cT3,cT4, any cN category, M0), or any cT cN+ M0 with the following specifications:
• • ECOG-Score ≤ 2
• • Patient is fit to undergo surgery (either subtotal or total gastrectomy, transhiatal or abdominothoracic esophagectomy)
• • No preceding cytotoxic or targeted therapy
• • No prior partial or complete tumor resection
• • Exclusion of distant metastasis by CT or MRI of thorax and abdomen, and optionally bone scan (if osseous lesions are suspected due to clinical signs)
• Exclusion Criteria:
• • Patients with distant metastasis
• • Known hypersensitivity against components of the neoadjuvant systemic treatment
• • Documented history of congestive heart failure NYHA ≥III, myocardial infarction within the past 3 months before the start of neoadjuvant treatment
• • Uncontrollable high-risk cardiac arrhythmia, e.g. significant ventricular arrhythmia
• • Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated early stage cancers such as basal cell carcinoma of the skin and in situ carcinoma of the cervix or the bladder.