Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display

1554 - NORDIC9: A randomized phase II trial exploring treatment of older patients with metastatic colorectal cancer (mCRC) by comparing full dose monotherapy (S-1 followed by irinotecan) with reduced combination regimen (S-1/oxaliplatin followed by S-1/irinotecan)


08 Oct 2016


Poster Display


Stine Winther


Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370


S.B. Winther1, P. Østerlund2, Å. Berglund3, B. Glimelius4, C. Qvortrup1, H. Sorbye5, P. Pfeiffer1

Author affiliations

  • 1 Department Of Oncology, Odense University Hospital, 5000 - Odense C/DK
  • 2 Department Of Oncology, HUCH Helsinki University Central Hospital, 00029 - Helsinki/FI
  • 3 Department Of Oncology, University Hospital Uppsala Akademiska Sjukhuset, 751 85 - Uppsala/SE
  • 4 Department Of Immunology, Genetics And Pathology, University Hospital Uppsala Akademiska Sjukhuset, 751 85 - Uppsala/SE
  • 5 Department Of Oncology, Haukeland Universitetssykehus, 5021 - Bergen/NO


Abstract 1554


More than half of the patients diagnosed with mCRC are elderly (70+ years). Older patients comprise a heterogeneous group, they are underrepresented in clinical trials, and knowledge about the best treatment strategy in patients who are not candidates for standard full-dose combination therapy is sparse and it is uncertain whether full dose or reduced dose chemotherapy is the optimal strategy. The oral prodrug S-1 (Teysuno®) is well tolerated as monotherapy and in combinations and could be an ideal drug for older patients (Winther et al, Acta Oncol 2015), but more data to predict toxicity and efficacy is needed. The NORDIC9 study will add knowledge on how to select and tailor the optimal treatment strategy for older mCRC patient who are not candidates for standard combination therapy.

Trial design

NORDIC9 is a randomized phase II trial exploring treatment of older mCRC patients (≥ 70 years) who are not candidates to full-dose combination therapy, by comparing full dose monotherapy (S-1 30 mg/m2 twice daily days 1-14 every 3 weeks, followed by second line irinotecan 250-350 mg/m2 iv day 1 every 3 weeks or 180-240 mg/m2 iv day 1 every 2 weeks) with reduced dose (80%) combination therapy regimen (S-1 20 mg/m2 days 1-14 + oxaliplatin 100 mg/m2 iv day 1 every 3 weeks, followed by second line S-1 20 mg/m2 days 1-14 + irinotecan 180 mg/m2 day 1 every 3 week). Bevacizumab (7.5 mg/kg) may be added at the discretion of the treating clinician. Geriatric screening tools (G-8, VES-13, Timed-Up-and-Go, Grip strength), Charlson Comorbidity Index and Quality of Life (EORTC QLQ-C30) will be evaluated at baseline. Blood samples and tumor tissue will be collected to investigate predictive value. Enrollment was initiated in March 2015, and 52 patients are currently included. Primary endpoint is progression-free survival and secondary endpoints are time-to-failure of strategy, overall survival, response rate, toxicity, and correlations between biomarkers, pre-treatment characteristics and geriatric assessments.

Clinical trial identification

EudraCT 2014-000394-39

Legal entity responsible for the study

Clinical Research Unit, Department of Oncology, Odense University Hospital




P. Østerlund: Amgen, Bayer, Baxalta, Celgene, Eli Lilly, Merck, Nordic Drugs, Prime Oncology, Roche, Sanofi. P. Pfeiffer: Research grant: Taiho. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings