Paclitaxel-HDFL for Locally Advanced and Recurrent/Metastatic Gastric Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-30

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is to evaluate the efficacy,response rate,time to treatment failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen

Detailed Description

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In the treatment of metastatic breast cancer, paclitaxel followed by weekly HDFL has been shown to have a 55% response rate in anthracycline-resistant patient. Recently, regimen combining paclitaxel and moderately-high-dose 5-FU (1500mg/m2) has had response rate up to 61.5% (including 23%CR) in a small group of gastric cancer patients (8 responders in 13 patients). Thus, the sequential use of weekly paclitaxel followed by weekly HDFL regimen may become a new generation of chemotherapeutic regimen for the treatment of gastric cancer. Further study with a larger group of patients and further testing of possible schedules of administration are warranted.

Conditions

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Locally Advanced and Recurrent/Metastatic Gastric Cancer

Keywords

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Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paclitaxel-HDFL

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ann-Lii Cheng, M.D.,Ph.D.

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Other Identifiers

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36-3

Identifier Type: -

Identifier Source: org_study_id