Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506623
Status:
UNKNOWN
Last Update Posted:
2007-07-25
First Post:
2007-07-23
Brief Title:
Preoperative Chemoradiotherapy With Capecitabine Plus Irinotecan in Rectal Cancer
Sponsor:
National Cancer Center Korea
Organization:
National Cancer Center Korea
Study Overview
Official Title:
A Phase Ⅱ Study of Pre-Operative Concurrent Chemoradiotherapy With Capecitabine Plus Irinotecan in Resectable Rectal Cancer
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This study is to evaluate the pathologic complete response rate to pre-operative concurrent chemoradiotherapy with capecitabine plus irinotecan in resectable rectal cancer
Detailed Description:
This study is an open-label single center nonrandomized phase II study Daily fractions of radiotherapy at 18 Gy to total of 45 Gy to tumor and draining lymph nodes and followed by a coned-down boost of 54 Gy to the tumor were delivered concurrently with chemotherapy
Chemotherapy starts at day 1 of radiotherapy Capecitabine is administered orally at a dose of 825 mgm2 twice daily during weekdays Monday to Friday every week during radiotherapy Irinotecan 40 mgm2 is given intravenously once a week D 1 8 15 22 29
Six 2 weeks after completion of chemoradiotherapy curative surgery is performed
Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery Capecitabine 1250 mgm2 twice daily on days 1-14 every 21 days will be administered for 18 weeks
Chemotherapy starts at day 1 of radiotherapy Capecitabine is administered orally at a dose of 825 mgm2 twice daily during weekdays Monday to Friday every week during radiotherapy Irinotecan 40 mgm2 is given intravenously once a week D 1 8 15 22 29
Six 2 weeks after completion of chemoradiotherapy curative surgery is performed
Post-operative chemotherapy with capecitabine will be given to all patients 3-6 weeks after surgery Capecitabine 1250 mgm2 twice daily on days 1-14 every 21 days will be administered for 18 weeks
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