Trial | NCT01517009  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
Study Started
Jun 30
2008
Primary Completion
Nov 30
2012
Study Completion
May 31
2013
Last Update
Jun 26
2013
Estimate

Drug Docetaxel

60 mg/m2, 1 gift every 3 weeks, in total 4 gifts

  • Other names: Taxotere

Drug cisplatin

60 mg/m2, one gift every three weeks, in total 4 gift

Drug Capecitabine

1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles

  • Other names: Xeloda

Procedure D1extra-resection

An extended lymphadenectomy compared to a D1 resection for gastric cancer

Criteria 

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
No Results Posted