Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506844
Status:
UNKNOWN
Last Update Posted:
2007-07-25
First Post:
2007-07-23
Brief Title:
Preoperative Chemoradiotherapy With Cetuximab 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 Cetuximab Irinotecan and Capecitabine 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:
ERBIRIX
Brief Summary:
This study is to estimate the pathologic complete response rate of cetuximab irinotecan and capecitabine concurrent with radiotherapy given preoperatively in patients with resectable rectal cancer
Detailed Description:
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 are delivered concurrently with chemotherapy
Cetuximab 400 mgm2 is given intravenously on D-6 1 week before radiation followed by 250 mgm2 once a week D 1 8 15 22 29
Administration of irinotecan and capecitabine starts on day 1 of radiotherapy Capecitabine is administered orally at a dose of 825 mgm2 twice daily during weekdays Monday to Friday during radiotherapy Irinotecan 40 mgm2 is given intravenously once a week D 1 8 15 22 29
Four to eight weeks after completion of chemoradiotherapy curative surgery is performed
Safety evaluation of the study will be performed after the first 6 patients treated If more than 1 out of 6 patients received less than 70-80 of planned dose of capecitabine or irinotecan the dosage of chemotherapy in the further study patients will be adjusted by a protocol amendment
Cetuximab 400 mgm2 is given intravenously on D-6 1 week before radiation followed by 250 mgm2 once a week D 1 8 15 22 29
Administration of irinotecan and capecitabine starts on day 1 of radiotherapy Capecitabine is administered orally at a dose of 825 mgm2 twice daily during weekdays Monday to Friday during radiotherapy Irinotecan 40 mgm2 is given intravenously once a week D 1 8 15 22 29
Four to eight weeks after completion of chemoradiotherapy curative surgery is performed
Safety evaluation of the study will be performed after the first 6 patients treated If more than 1 out of 6 patients received less than 70-80 of planned dose of capecitabine or irinotecan the dosage of chemotherapy in the further study patients will be adjusted by a protocol amendment
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