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Brief Title: Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
Official Title: Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy of Active Post-resection/Ablation Therapy in Patients With Metastatic Colorectal Cancer
Study ID: NCT05008809
Brief Summary: This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI/mFOLFOX-6 as additive treatment (Arm A) versus active follow-up/surveillance (Arm B).
Detailed Description: The trial will consist of both a clinical and translational part. During the study, re-assessments (radiologic assessment, blood and QoL) will be conducted for all trial subject of the trial every 3 months. Tumor biopsies will be collected at screening (baseline sample) and in case of relapse of disease if a new tumor sample is obtained. The objective of the re-assessments is detection of relapse either radiologically or within the translational material (blood samples with ctDNA dynamics and tumor - if available from relapses). CT scans of thorax/abdomen and/or MRI scans will be performed every 3 months within the 2 years after randomization. After the first two relapse-free years, intervals should be stretched to 6 months in the third and following years after study start. Structured follow-up for up to 60 months after randomization should be maintained for both arms. Patients in Arm A receive additive study drug intervention (mFOLFOXIRI or mFOLFOX-6) for up to six months (12 cycles) after randomization with additional clinical and safety assessments.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Klinikum St. Marien Amberg, Amberg, , Germany
Helios Klinikum Bad Saarow, Bad Saarow, , Germany
Klinikum Bayreuth, Bayreuth, , Germany
Charité Universitätsmedizin Berlin, Berlin, , Germany
Helios Klinikum Emil von Behring, Berlin, , Germany
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim, Berlin, , Germany
Vivantes Klinikum am Urban Berlin, Berlin, , Germany
Vivantes Klinikum Spandau Berlin, Berlin, , Germany
St. Josef-Hospital Bochum, Bochum, , Germany
Johanniterkrankenhaus Bonn, Bonn, , Germany
Diakonie-Krankenhaus Bremen, Bremen, , Germany
Klinikum Chemnitz, Chemnitz, , Germany
Klinikum Darmstadt, Darmstadt, , Germany
DONAUISAR Klinikum Deggendorf, Deggendorf, , Germany
Städtisches Klinikum Dessau, Dessau, , Germany
Onkologische-Gemeinschaftspraxis Dresden, Dresden, , Germany
Onkozentrum Dresden, Dresden, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Kliniken Essen-Mitte, Essen, , Germany
Universitätsklinikum Essen, Essen, , Germany
KHNW Frankfurt, Frankfurt, , Germany
Markus-Krankenhaus Frankfurt, Frankfurt, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Gemeinschaftspraxis internistische Onkologie Fürth, Fürth, , Germany
Niels-Stensen Kliniken Georgsmarienhütte, Georgsmarienhütte, , Germany
Praxis Hämatologie Onkologie Gießen, Gießen, , Germany
Universitätsmedizin Göttingen, Göttingen, , Germany
Universitätsklinikum Halle, Halle, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
St. Anna Hospital Herne, Herne, , Germany
Universitätsklinikum des Saarlandes, Homburg, , Germany
Klinikum Ingolstadt GmbH, Ingolstadt, , Germany
Universitätsklinikum Jena, Jena, , Germany
Kliniken der Satdt Köln, Köln, , Germany
Klinikum Landshut, Landshut, , Germany
VK&K Studien Landshut, Landshut, , Germany
Studienzentrum UnterEms Leer, Leer, , Germany
Universitätsklinikum Leipzig, Leipzig, , Germany
Klinikum Leverkusen, Leverkusen, , Germany
Klinikum Lippe, Lippe, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
Klinikum Magdeburg, Magdeburg, , Germany
Universitätsmedizin Mainz, Mainz, , Germany
OnkoNet Marburg GmbH, Marburg, , Germany
Philipps-Universität Marburg, Marburg, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Kliniken Maria Hilf Mönchengladbach, Mönchengladbach, , Germany
Klinikum der Universität München, München, , Germany
Klinikum rechts der Isar TU München, München, , Germany
München Klinik Bogenhausen, München, , Germany
München Klinik Neuperlach, München, , Germany
Gemeinschaftspraxis Münster, Münster, , Germany
Universitätsklinikum Münster, Münster, , Germany
Friedrich-Ebert-Krankenhaus Neumünster, Neumünster, , Germany
Lukaskrankenhaus Neuss, Neuss, , Germany
Klinikum Nürnberg, Nürnberg, , Germany
Pi.Tri-Studien GmbH Offenburg, Offenburg, , Germany
Klinikum Passau, Passau, , Germany
Schwerpunktpraxis Penzberg, Penzberg, , Germany
Ernst von Bergmann Klinikum Potsdam, Potsdam, , Germany
Studienzentrum Onkologie Ravensburg, Ravensburg, , Germany
Krankenhaus Barmherzige Brüder Regensburg, Regensburg, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Kreiskliniken Reutlingen, Reutlingen, , Germany
Mathias Spital Rheine, Rheine, , Germany
RoMed Klinikum Rosenheim, Rosenheim, , Germany
Universitätsmedizin Rostock, Rostock, , Germany
DIAK Klinikum Schwäbisch Hall, Schwäbisch Hall, , Germany
Marienkrankenhaus Siegen, Siegen, , Germany
Klinikum Stuttgart, Stuttgart, , Germany
Marienhospital Stuttgart, Stuttgart, , Germany
Krankenhaus der Barmherzigen Brüder Trier, Trier, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Klinikum Wetzlar, Wetzlar, , Germany
Onkologisches Zentrum Wolfsburg-Helmstedt, Wolfsburg, , Germany
Petrus-Krankenhaus Wuppertal, Wuppertal, , Germany
Gemeinschaftspraxis Würzburg, Würzburg, , Germany
Name: Dominik Modest, Prof. Dr.
Affiliation: Charite University, Berlin, Germany
Role: PRINCIPAL_INVESTIGATOR