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An Effective and Well-Tolerated Regimen of Docetaxel Plus High-Dose 5-Fluorouracil and Leucovorin(HDFL)to Treat Inoperable Advanced or Metastatic Gastric Cancer

NCT00270543 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2009-02-09

No results posted yet for this study

Summary

The primary endpoint of this phase II trial is the objective tumor response rate. The secondary endpoints include treatment-related toxicity, the clinical benefit response defined by the change in performance status and body weight, the change in quality of life, progression free survival and overall survival. Simon's optimal two-stage design will be used to determine the patient number.

Conditions

  • Stomach Neoplasms

Interventions

DRUG

Taxotere, Fluorouracil, Leucovorin

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Principal Investigators

  • Kun Huei Yeh, Ph.D. · Far Eastern Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Countries

  • Taiwan

Study Locations

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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 NCT00270543 on ClinicalTrials.gov