Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190515
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2005-09-12
Brief Title:
A Trial Comparing Adjuvant Oral UFTLV to 5-FUl-LV in Stage III Colorectal Cancer JCOG-0205-MF
Sponsor:
Haruhiko Fukuda
Organization:
Japan Clinical Oncology Group
Study Overview
Official Title:
Randomized Phase III Trial Comparing Adjuvant Oral UFTLV to 5-FUl-LV in Stage III Colorectal Cancer JCOG-0205-MF
Status:
COMPLETED
Status Verified Date:
2016-09
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:
To evaluate the clinical effectiveness of oral UFTLV comparing 5-FUl-LV as adjuvant therapy for stage III colorectal cancer
Detailed Description:
Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy we conducted randomized controlled trial comparing the oral combination chemotherapy UFTLV to the standard intravenous combination chemotherapy 5-FUl-LV in stage III colorectal cancer
UFTLV UFT 300mgm2day and LV 75mgday orally for 28days with 7days rest repeated five times every 5 weeks
5-FUl-LV 5-FU 500mgm2 l-LV 250mgm2 weekly administration for 6 times repeated three times every 8 weeks
Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate
UFTLV UFT 300mgm2day and LV 75mgday orally for 28days with 7days rest repeated five times every 5 weeks
5-FUl-LV 5-FU 500mgm2 l-LV 250mgm2 weekly administration for 6 times repeated three times every 8 weeks
Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C000000193 | None | None | None |