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Nordic 8 - A Phase II Trial

NCT01867697 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2020-10-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cetuximab

DRUG

Irinotecan

DRUG

Oxaliplatin

DRUG

Folinic Acid

DRUG

Calcium Carbonate

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • Per Pfeiffer

    lead OTHER

Principal Investigators

  • Per Pfeiffer, Professor, MD, PhD · Odense University Hospital

  • Halfdan Sørbye, Professor, MD · Haukeland University Hospital

  • Bengt Glimelius, Professor, MD · Akademiske Sygehus, Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867697 on ClinicalTrials.gov