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Zang Fu theory |
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Clinical Trial: Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer
This study has been completed.
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Purpose
The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin adn weekly HDFL in recurrentor metastatic esophageal carcinoma patients who need palliative Chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
| Esophageal Cancer | Drug: Paclitaxel,Cisplatin,5-Fu,Folic Acid | Phase II |
MedlinePlus related topics: Esophageal Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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
Further Study Details:
Primary Outcomes: Response rate
Secondary Outcomes: Overall survival; Progression-free survival; Toxicity
Expected Total Enrollment: 40
Secondary Outcomes: Overall survival; Progression-free survival; Toxicity
Expected Total Enrollment: 40
Study start: January 2001; Study completion: July 2005
Last follow-up: July 2005; Data entry closure: July 2005
The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin adn weekly HDFL in recurrentor metastatic esophageal carcinoma patients who need palliative Chemotherapy. The secondary objectives include overall survival, progression-free survival, and toxicity.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Pathologically proven esophageal squamous cell or adenocarcinoma Recurrenceor 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)
Location Information
Taiwan
Department of Oncology, National Taiwan University Hospital, Taipei, 100, Taiwan
Study chairs or principal investigators
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
More Information
Study ID Numbers: 159I9
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154700
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154700
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13
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