A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer (DoCCS)
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The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.
The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer. [ Time Frame: 18 weeks ]
Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle.
Secondary Outcome Measures :
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer [ Time Frame: 30 days ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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