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

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. Identifier: NCT01517009
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : June 26, 2013
Eindhoven Cancer Registry
Information provided by (Responsible Party):
Anneriet Dassen, Jeroen Bosch Ziekenhuis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Docetaxel Drug: cisplatin Drug: Capecitabine Procedure: D1extra-resection Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
Study Start Date : June 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Intervention Details:
  • 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

Primary Outcome Measures :
  1. 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 :
  1. The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517009

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VieCuri Hospital
Venlo, Limburg, Netherlands, 5912 BL
Elkerliek Hospital
Helmond, Noord Brabant, Netherlands, 5700 AB
Jeroen Bosch Hospital
Den Bosch, Noord-Brabant, Netherlands, 5200 ME
Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
Maxima Medical Centre
Veldhoven, Noord-Brabant, Netherlands, 5500 MB
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
Eindhoven Cancer Registry

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Responsible Party: Anneriet Dassen, Ms A.E. Dassen, MD, Principle Investigator, Jeroen Bosch Ziekenhuis Identifier: NCT01517009     History of Changes
Other Study ID Numbers: DoCCS
Dutch trialregister ( Registry Identifier: NTR2306 )
2007-007273-23 ( EudraCT Number )
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013
Keywords provided by Anneriet Dassen, Jeroen Bosch Ziekenhuis:
Neo-adjuvant chemotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic