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

June 25, 2013 updated by: Anneriet Dassen, Jeroen Bosch Ziekenhuis
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Venlo, Limburg, Netherlands, 5912 BL
        • VieCuri Hospital
    • Noord Brabant
      • Helmond, Noord Brabant, Netherlands, 5700 AB
        • Elkerliek Hospital
    • Noord-Brabant
      • Den Bosch, Noord-Brabant, Netherlands, 5200 ME
        • Jeroen Bosch Hospital
      • Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
        • Catharina hospital
      • Veldhoven, Noord-Brabant, Netherlands, 5500 MB
        • Maxima Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeroen Bosch Ziekenhuis

Collaborators

Eindhoven Cancer Registry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DoCCS
  • Dutch trialregister (Registry Identifier: NTR2306)
  • 2007-007273-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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