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