Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01867697
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2012-06-21
Brief Title:
Nordic 8 - A Phase II Trial
Sponsor:
Per Pfeiffer
Organization:
Odense University Hospital
Study Overview
Official Title:
Potentially Resectable Metastatic Colorectal Cancer With Wild-type KRAS and BRAF Alternating Chemotherapy Plus Cetuximab - A Randomised Phase II Trial
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in patients with potential resectable KRAS wildtype metastatic colorectal cancer
All patients will be randomized to biweekly cetuximab 500 mgm2 in combination with arm A FOLFIRI irinotecan 180 mgm2 IV leucovorin 400 mgm2 IV 5FU bolus 400 mgm2 IV and 46 hours 5FU infusion of 2400 mgm2 every 2 weeks or arm B FOLFIRI alternating with FOLFOX6 Oxaliplatin 85 mgm2 IV leucovorin 400 mgm2 IV 5FU bolus 400 mgm2 IV and 46 hours 5FU infusion of 2400 mgm2 every 2 weeks
Primary objective response rate RECIST 11 in patients with with potential resectable KRAS wildtype metastatic colorectal cancer
Secondary objectives Resection rate PFS OS Quality of life tolerability Biomarker evaluation to measure plasma biomarkers Tumour blocks and sequential serum and plasma will be collected to search for markers that may predict efficacy including respectability and safety
All patients will be randomized to biweekly cetuximab 500 mgm2 in combination with arm A FOLFIRI irinotecan 180 mgm2 IV leucovorin 400 mgm2 IV 5FU bolus 400 mgm2 IV and 46 hours 5FU infusion of 2400 mgm2 every 2 weeks or arm B FOLFIRI alternating with FOLFOX6 Oxaliplatin 85 mgm2 IV leucovorin 400 mgm2 IV 5FU bolus 400 mgm2 IV and 46 hours 5FU infusion of 2400 mgm2 every 2 weeks
Primary objective response rate RECIST 11 in patients with with potential resectable KRAS wildtype metastatic colorectal cancer
Secondary objectives Resection rate PFS OS Quality of life tolerability Biomarker evaluation to measure plasma biomarkers Tumour blocks and sequential serum and plasma will be collected to search for markers that may predict efficacy including respectability and safety
Detailed Description:
None
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