MODUL—a multicenter randomized clinical trial of biomarker-driven maintenance therapy following first-line standard induction treatment of metastatic colorectal cancer: an adaptable signal-seeking approach

Hans Joachim Schmoll, Dirk Arnold, Aimery de Gramont, Michel Ducreux, Axel F Grothey, Peter J. O’Dwyer, Eric Van Cutsem, Frank Hermann, Ivan Bosanac, Belguendouz Bendahmane, Christoph Mancao, Josep Tabernero

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

Purpose: The old approach of one therapeutic for all patients with mCRC is evolving with a need to target specific molecular aberrations or cell-signalling pathways. Molecular screening approaches and new biomarkers are required to fully characterize tumours, identify patients most likely to benefit, and predict treatment response. Methods: MODUL is a signal-seeking trial with a design that is highly adaptable, permitting modification of different treatment cohorts and inclusion of further additional cohorts based on novel evidence on new compounds/combinations that emerge during the study. Results: MODUL is ongoing and its adaptable nature permits timely and efficient recruitment of patients into the most appropriate cohort. Recruitment will take place over approximately 5 years in Europe, Asia, Africa, and South America. The design of MODUL with ongoing parallel/sequential treatment cohorts means that the overall size and duration of the trial can be modified/prolonged based on accumulation of new data. Conclusions: The early success of the current trial suggests that the design may provide definitive leads in a patient-friendly and relatively economical trial structure. Along with other biomarker-driven trials that are currently underway, it is hoped that MODUL will contribute to the continuing evolution of clinical trial design and permit a more ‘tailored’ approach to the treatment of patients with mCRC.

Original languageEnglish (US)
Pages (from-to)1197-1204
Number of pages8
JournalJournal of Cancer Research and Clinical Oncology
Volume144
Issue number6
DOIs
StatePublished - Jun 1 2018

Keywords

  • Biomarker
  • FOLFOX + bevacizumab
  • Metastatic colorectal cancer
  • MODUL
  • Signal seeking
  • Switch maintenance therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Schmoll, H. J., Arnold, D., de Gramont, A., Ducreux, M., Grothey, A. F., O’Dwyer, P. J., Van Cutsem, E., Hermann, F., Bosanac, I., Bendahmane, B., Mancao, C., & Tabernero, J. (2018). MODUL—a multicenter randomized clinical trial of biomarker-driven maintenance therapy following first-line standard induction treatment of metastatic colorectal cancer: an adaptable signal-seeking approach. Journal of Cancer Research and Clinical Oncology, 144(6), 1197-1204. https://doi.org/10.1007/s00432-018-2632-6