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Taxotere New Indication - Gastric Cancer Treatment Registration Trial

NCT00811447 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2012-08-31

No results posted yet for this study

Summary

Primary objective:

To detect a statistically significant increase in time to progression (TTP) of disease for the test group (Taxotere® \[Docetaxel\] combined with cisplatin and 5-fluorouracil \[TCF\]) relative to the control group (Cisplatin combined with 5-fluorouracil\[CF\])

Secondary objectives:

* To detect a statistically significant increase in overall survival (OS) for the test group relative to the control group.
* To compare response rate (RR), time to treatment failure (TTF), duration of responses, safety profiles, quality of life (QOL), and disease-related symptoms.

Conditions

  • Stomach Neoplasms

Interventions

DRUG

5-fluorouracil

600 mg/m²/day intravenous

DRUG

Cisplatin

60 mg/m² or 75 mg/m² intravenous

DRUG

Docetaxel

60 mg/m² intravenous

Sponsors & Collaborators

Principal Investigators

  • Martin Thoenes · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811447 on ClinicalTrials.gov