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Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

NCT ID: NCT00154700

Last Updated: 2005-12-20

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

2001-01-31

Study Completion Date

2005-07-31

Brief Summary

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The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy.

Detailed Description

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The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy. The secondary objectives include overall survival, progression-free survival, and toxicity.

Conditions

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Esophageal Cancer

Keywords

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Combination,Chemotherapy,Esophageal 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,Cisplatin,5-Fu,Folic Acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pathologically proven esophageal squamous cell or adenocarcinoma Recurrence or metastasis Measurable disease (\> 1 X 1 cm) by CXR, CT scan or MRI,Age \> 18, KPS \> 60% , Cre \< 1.5mg/dl, AST/ALT \< 3.5 X N, Bil \< 2.0mg/dl WBC \> 4,000/mm3, ANC \> 2,000/ mm3, Plt \> 100,000/mm3

Exclusion Criteria

* Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only (except \> 2 months)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University hospital

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

Role: STUDY_CHAIR

Department of Oncology, National Taiwan University Hospital

Locations

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Department of Oncology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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159I9

Identifier Type: -

Identifier Source: org_study_id