Hans-Joachim Schmoll1, Dirk Arnold2, Aimery de Gramont3, Michel Ducreux4, Axel Grothey5, Peter J O'Dwyer6, Eric Van Cutsem7, Frank Hermann8, Ivan Bosanac9, Belguendouz Bendahmane9, Christoph Mancao10, Josep Tabernero11. 1. Division of Clinical Oncology Research, University Clinic Halle (Saale), Martin-Luther-University Halle-Wittenberg, Ernst-Grube-Str. 40, 06120, Halle, Germany. hans-joachim.schmoll@uk-halle.de. 2. Instituto CUF de Oncologia, Lisbon, Portugal. 3. Hôpital Saint Antoine, Paris, France. 4. Gustave Roussy, Villejuif, Université Paris Saclay, Paris, France. 5. Mayo Clinic College of Medicine, Rochester, MN, USA. 6. Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. 7. University Hospitals Gasthuisberg, Leuven and KULeuven, Leuven, Belgium. 8. Molecular Partners, Zurich (previously F. Hoffmann-La Roche Ltd), Basel, Switzerland. 9. F. Hoffmann-La Roche Ltd, Basel, Switzerland. 10. Genentech Inc., Basel, Switzerland. 11. Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.
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.
RCT Entities:
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.
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