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Nordic 8 - A Phase II Trial

ABSTRACT: 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.

DISEASE(S): Metastatic Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2145885 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Alternating oxaliplatin and irinotecan doublet treatment schedules. Arm A:Clinician’s choice doublet chemotherapy (standard chemotherapy) Arm B: Alternating schedule of 2 cycles of oxaliplatin doublet chemotherapy and 2 cycles of irinotecan doublet chemotherapy, i.e. mFOLFOX6-FOLFIRI or CAPOX-CAPIRI In both arms, initial combination chemotherapy will be given for 4-6 months as per standard of care, followed by maintenance fluoropyrimidine chemotherapy until disease progression, unmanageable toxicity or patient or treating clinician’s request. Biologic therapy (bevacizumab or an EGFR inhibitor) will be given according to clinician’s choice; however, as per guidelines, EGFRI use will be restricted to patients with left-sided RAS wild-type tumours. 1) Intervention drug - Doublet chemotherapy (mFOLFOX6, FOLFIRI, CAPOIX or CAPIRI) mFOLFOX6 Frequency: every 2 weeks Oxaliplatin 85 mg/m2 IV day 1 Leucovorin 50 mg IV day 1 Fluorouracil (5FU) 400 mg/m2 IV day 1 Fluorouracil (5FU) infusion 2,400 mg/m2 over 46 hours day 1-2 FOLFIRI Frequency: every 2 weeks Irinotecan 180 mg/m2 IV day 1 (150 mg/m2 if > 70 y.o.) Leucovorin 50 mg IV day 1 Fluorouracil (5FU) 400 mg/m2 IV day 1 Fluorouracil (5FU) infusion 2,400 mg/m2 over 46 hours day 1-2 CAPOX Frequency: every 3 weeks Oxaliplatin 130 mg/m2 IV day 1 Capecitabine 850-1000 mg/m2 orally BD days 1-14 CAPIRI Frequency: every 3 weeks Irinotecan 240 mg/m2 IV day 1 Capecitabine 850-1000 mg/m2 orally BD days 1-14 New drug schedules have been created for the hospital staff to keep track of the alternating cycles. Whether a participant receives mFOLFOX6-FOLFIRI or CAPOX-CAPIRI is decided by the treating practitioner, based on their usual treatment practice. When a patient is on the interventional treatment e.g. CAPOX-CAPIRI, the different treatments are staggered every 3 weeks. For FOLFOX-FOLFIRI, the the different treatments are stag Primary outcome(s): To examine the feasibility of a multi-centre prospective registry-based randomised clinical trial evaluating alternating oxaliplatin and irinotecan doublet schedules vs. continuous doublet chemotherapy during initial treatment of metastatic colorectal cancer. The primary feasibility endpoint will be evaluated by recruitment rate, defined as the proportion of eligible mCRC patients who enrol onto this study. [Eligible participants will be recruited over 1.5 years. All participants will be followed until death or study completion. ] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy

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Nordic 8 - A Phase II Trial

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