Back to resultsTwice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Paclitaxel,Cisplatin,5-Fu,Folic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Combination,Chemotherapy,Esophageal Cancer
Eligibility Criteria
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)
Sites / Locations
- Department of Oncology, National Taiwan University Hospital
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Overall survival
Progression-free survival
Toxicity
Full Information
NCT ID
NCT00154700
First Posted
September 8, 2005
Last Updated
December 19, 2005
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00154700
Brief Title
Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
Combination,Chemotherapy,Esophageal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Paclitaxel,Cisplatin,5-Fu,Folic Acid
Primary Outcome Measure Information:
Title
Response rate
Secondary Outcome Measure Information:
Title
Overall survival
Title
Progression-free survival
Title
Toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, M.D., Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, M.D.,Ph.D
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer
We'll reach out to this number within 24 hrs