A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer

Inclusion criteria

• Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
• ASA 2 or less
• Age 18 years or more
• No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
• Haematology/Renal function/Liver function within designated range
• Patient's consent form obtained, signed and dated before beginning specific protocol procedures
• absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
• before patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations.

Exclusion criteria

• Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer
• Other current serious illness or medical conditions
• Severe cardiac illness (NYHA class III-IV)
• Significant neurologic or psychiatric disorders
• Uncontrolled infections
• Active DIC
• Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
• Known hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU
• Definite contraindications for the use of corticosteroids
• Use of immunosuppressive or antiviral drugs
• Any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period
• Pregnant or lactating women
• Patients with reproductive potential not implementing adequate contraceptive measures