Back to resultsRandomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
Primary Purpose
Stomach Neoplasm
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
XRP6976
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasm focused on measuring docetaxel, stomach neoplasm
Eligibility Criteria
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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00290966
Brief Title
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
docetaxel, stomach neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
610 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
XRP6976
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaffer Ajani, MD
Organizational Affiliation
MD Anderson Cancer Center, Houston, Texas, US
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
E. Van Cutsem, MD
Organizational Affiliation
University hospital Gasthuisberg, Leuven, Belgium
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
17075117
Citation
Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7. doi: 10.1200/JCO.2006.06.8429.
Results Reference
result
Learn more about this trial
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
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