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Spots Global Cancer Trial Database for Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

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Trial Identification

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

Interventions

mFOLFOX6
mFOLFOXIRI

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Dominik Modest, Prof. Dr.

Affiliation: Charite University, Berlin, Germany

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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