Status:
COMPLETED
Randomized Multicenter Study Comparing Docetaxel Plus Cisplatin and 5-FU to Cisplatin Plus 5-FU in Advanced Gastric Cancer
Lead Sponsor:
Sanofi
Conditions:
Stomach Neoplasm
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT00290966
Start Date
October 1 1998
End Date
May 1 2003
Last Update
April 29 2009
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