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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 25, 2012
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Eindhoven Cancer Registry
Information provided by (Responsible Party):
Anneriet Dassen, Jeroen Bosch Ziekenhuis
October 21, 2011
January 25, 2012
June 26, 2013
June 2008
November 2012   (Final data collection date for primary 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. [ 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.
Same as current
Complete list of historical versions of study NCT01517009 on ClinicalTrials.gov Archive Site
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Docetaxel
    60 mg/m2, 1 gift every 3 weeks, in total 4 gifts
    Other Name: 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 Name: Xeloda
  • Procedure: D1extra-resection
    An extended lymphadenectomy compared to a D1 resection for gastric cancer
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2013
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Dutch trialregister ( Registry Identifier: NTR2306 )
2007-007273-23 ( EudraCT Number )
Not Provided
Not Provided
Anneriet Dassen, Jeroen Bosch Ziekenhuis
Jeroen Bosch Ziekenhuis
Eindhoven Cancer Registry
Not Provided
Jeroen Bosch Ziekenhuis
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP