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Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: February 9, 2006
Last updated: April 28, 2009
Last verified: April 2009

Phase II:

Primary objective: to select one of the 2 test arms (docetaxel with cisplatin, docetaxel with cisplatin and 5-FU), based primarily on complete responses, to advance to a phase III survival comparison against the CDDP + 5-FU control arm.

Secondary objective: to evaluate the quantitative and qualitative safety profile of the 2 test groups.

Phase III:

Primary objective: to detect a statistically significant increase in time to progression (TTP) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).

Main secondary objective: to detect a statistically significant increase in overall survival (OS) for the test arm (docetaxel plus cisplatin and 5-FU) relative to the control arm (cisplatin plus 5-FU).

Other secondary objectives: to compare response rates, time to treatment failure, duration of response, safety profiles, quality of life and disease-related symptoms.Socio-economic data will be collected in order to be able to perform an analysis by country when necessary.

Condition Intervention Phase
Stomach Neoplasm Drug: XRP6976 Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Randomized Multicentre Phase II/III Study of Docetaxel in Combination With Cisplatin (CDDP) or Docetaxel in Combination With 5-Fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients With Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • to detect a significant increase in time to progression in favor of docetaxel plus cisplatin and 5-FU compared to cisplatin plus 5-FU. Tumor assessments (assessed with WHO criteria) had to be performed every 8 weeks until progression

Secondary Outcome Measures:
  • Patients were to be followed until death (overall survival). Clinical and laboratory were assessed with NCIC-CTG scale, before each cycle. Quality of life and clinical benefit were assessed every 2 weeks until progression and then every 3 months.

Estimated Enrollment: 610
Study Start Date: October 1998
Estimated Study Completion Date: May 2003

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient's consent form obtained, signed and dated before beginning specific protocol procedures.
  • Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven.
  • Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion (e.g. lymph node).
  • Performance status Karnofsky index > 70%.
  • Life expectancy of more than 3 months.
  • Adequate haematological and biochemistry parameters
  • No prior palliative chemotherapy, previous adjuvant (and/or neo-adjuvant) chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant (or neo-adjuvant) therapy and first relapse.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients (M/F) with reproductive potential not implementing adequate contraceptive measures.
  • Other tumor type than adenocarcinoma (leiomyosarcoma ; lymphoma).
  • Any prior palliative chemotherapy. Prior adjuvant (and/or neo-adjuvant) chemotherapy with a first relapse within 12 months from the end of adjuvant (or neo-adjuvant).
  • Prior treatment with taxanes. Prior CDDP as adjuvant (and/or neo-adjuvant) chemotherapy with cumulative dose > 300 mg/m².
  Contacts and Locations
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Please refer to this study by its identifier: NCT00290966

Sponsors and Collaborators
Principal Investigator: Jaffer Ajani, MD MD Anderson Cancer Center, Houston, Texas, US
Principal Investigator: E. Van Cutsem, MD University hospital Gasthuisberg, Leuven, Belgium
  More Information

Publications: Identifier: NCT00290966     History of Changes
Other Study ID Numbers: EFC6044
Study First Received: February 9, 2006
Last Updated: April 28, 2009

Keywords provided by Sanofi:
stomach neoplasm

Additional relevant MeSH terms:
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 processed this record on June 23, 2017