Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154687
Status:
COMPLETED
Last Update Posted:
2007-07-31
First Post:
2005-09-08
Brief Title:
Weekly TP-HDFL in the Treatment of Advanced TCC
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Phase II Study of Weekly Paclitaxel Cisplatin and 24-Hour Infusion of High-Dose 5-Fluorouracil and LeucovorinWeekly TP-HDFL in the Treatment of Advanced Transitional Cell CarcinomaTCC
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival
Detailed Description:
Transitional cell carcinomaTCCof urotheliumincluding bladder ureter and renal pelvis TCCs was the most lethal urology malignancy in Taiwan In 1995 approximately 1300 new cases of TCC was diagnosed in Taiwan and more than 600 patients died of this disease Advanced TCC is a moderately chemosensitive disease A combination of methotrexate vinblastine and cisplatin with or without doxorubicin M-VAC or CMV has been widely used since 1980s Despite the response rate was as high as 40-70 the survival of these patients was only slightly increased from a median of 7 to 9 months for those who were treated with supportive care or cisplatin alone to a median of 12 months by cisplatin-based combination chemotherapy One of the reasons for the poor treatment results is the inevitable treatment-related toxicities related to conventional systemic chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None