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Completed

NCT Number: NCT00154700

Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

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.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Paclitaxel,Cisplatin,5-Fu,Folic Acid

Drug

Primary outcomes

  1. Response rate

Secondary outcomes

  1. Overall survival

  2. Progression-free survival

  3. Toxicity

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A Phase II Study of Twice Weekly Paclitaxel, Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Folinic Acid in the Treatment of Recurrent or Metastatic Esophageal Cancer

Important dates

Study start
2001
Study completion
2005
First posted
Sep 12, 2005
Registry last updated
Dec 20, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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