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

Phase 2
18 Years
Not Enrolling
Gastric Cancer

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Trial Information

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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.

Outcome Time Frame:

18 weeks

Safety Issue:



The Netherlands: METOPP

Study ID:




Start Date:

June 2008

Completion Date:

May 2013

Related Keywords:

  • Gastric Cancer
  • Neo-adjuvant chemotherapy
  • D1extra-resection
  • Stomach Neoplasms