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
  Purpose

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 Intervention Phase
Gastric Cancer
Drug: Docetaxel
Drug: cisplatin
Drug: Capecitabine
Procedure: D1extra-resection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jeroen Bosch Ziekenhuis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: June 2008
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517009

Locations
Netherlands
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
  More Information

No publications provided

Responsible Party: Anneriet Dassen, Ms A.E. Dassen, MD, Principle Investigator, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier: NCT01517009     History of Changes
Other Study ID Numbers: DoCCS, Dutch trialregister, 2007-007273-23
Study First Received: October 21, 2011
Last Updated: June 25, 2013
Health Authority: The Netherlands: METOPP

Keywords provided by Jeroen Bosch Ziekenhuis:
Neo-adjuvant chemotherapy
D1extra-resection

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014