Spots Global Cancer Trial Database for Nordic 8 - A Phase II Trial
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Trial Identification
Brief Title: Nordic 8 - A Phase II Trial
Official Title: Potentially Resectable Metastatic Colorectal Cancer With Wild-type KRAS and BRAF: Alternating Chemotherapy Plus Cetuximab - A Randomised Phase II Trial
Study ID: NCT01867697
Conditions
Study Description
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 mg/m2 in combination with arm A) FOLFIRI (irinotecan 180 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks) or arm B) FOLFIRI alternating with FOLFOX6 (Oxaliplatin: 85 mg/m2 IV, leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 46 hours 5FU infusion of 2400 mg/m2 every 2 weeks) . Primary objective: response rate (RECIST 1.1) 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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aalborg University Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Sydvestjysk Hospital, Esbjerg, , Denmark
Herlev University Hospital, Herlev, , Denmark
Herning Hospital, Herning, , Denmark
Naestved Hospital, Naestved, , Denmark
Odense University Hospital, Odense, , Denmark
Roskilde Hospital, Roskilde, , Denmark
Haukeland University Hospital, Bergen, , Norway
Trondheim University Hospital, Trondheim, , Norway
Akademiska University Hospital, Uppsala, , Sweden
Contact Details
Name: Per Pfeiffer, Professor, MD, PhD
Affiliation: Odense University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Halfdan Sørbye, Professor, MD
Affiliation: Haukeland University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Bengt Glimelius, Professor, MD
Affiliation: Akademiske Sygehus, Uppsala University
Role: PRINCIPAL_INVESTIGATOR
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