Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Eindhoven Cancer Registry
Information provided by (Responsible Party):
Anneriet Dassen, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01517009
First received: October 21, 2011
Last updated: June 25, 2013
Last verified: June 2013

October 21, 2011
June 25, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Completed
50
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01517009
DoCCS, Dutch trialregister, 2007-007273-23
Yes
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