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CompletedNCT00154700Updated Dec 20, 2005

Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

A Phase 2 interventional study of Paclitaxel,Cisplatin,5-Fu,Folic Acid in Esophageal Cancer, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-12-20.

Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Combination,Chemotherapy,Esophageal Cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 40 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only (except > 2 months)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugPaclitaxel,Cisplatin,5-Fu,Folic Acid
06

What researchers measure

Primary outcomes

  1. Response rate

Secondary outcomes

  1. Overall survival

  2. Progression-free survival

  3. Toxicity

07

Study locations

1 site
  • Department of Oncology, National Taiwan University Hospital
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00154700
Lead sponsor
National Taiwan University Hospital
First posted
Sep 12, 2005
Start date
Jan 2001
Completion
Jul 2005
Last update
Dec 20, 2005

Study contacts

Ann-Lii Cheng, M.D., Ph.D.
study chair · Department of Oncology, National Taiwan University hospital
Ann-Lii Cheng, M.D.,Ph.D
study chair · Department of Oncology, National Taiwan University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.

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