Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
3 other identifiers
interventional
507
1 country
79
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started Dec 2021
Longer than P75 for phase_3 colorectal-cancer
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedStudy Start
First participant enrolled
December 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2030
December 12, 2025
December 1, 2025
5.9 years
August 6, 2021
December 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) time
time from randomization to death or evidence of disease relapse/progression (whatever occurs first)
24 months
Secondary Outcomes (4)
Overall survival (OS)
at least 5 years after randomization
Control ol lesions
up to 5 years after randomization
(Serious) Adverse Events
up to 2 years after randomization
Quality of life (QoL)
up to 5 years after randomization
Study Arms (2)
Treatment
EXPERIMENTALActive treatment with mFOLFOXIRI or mFOLFOX6 or FOLFIRI q2w or CAPOX q3w up to six months followed by structured Follow-up for up to five years after randomization
Control
NO INTERVENTIONStructured Follow-up for up to five years after randomization
Interventions
Capecitabine: 1000 mg/m², oral 1-0-1 on d1-14 Oxaliplatin: 130 mg/m², 3h IV infusion on d1 Cycles are repeated on day 22. A total of up to 8 cycles isadministered.
Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Folinic acid: 400 mg/m², 1-2 h IV infusion on d1 5-FU: (optional: 400 mg/m² bolus, 2-5 min IV infusion), 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.
Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Irinotecan: 150 mg/m², 90 min IV infusion on d1 Folinic acid: 400 mg/m², 1-2 h IV infusion on d1 5-FU: 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.
Folinic acid: 400mg/m², 1-2h IV Infusion on d1 5-FU: 2400 mg/m², 46 h IV infusion on d1 Irinotecan: 180 mg/m², 90-120 min IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles is administered.
Eligibility Criteria
You may qualify if:
- Patient's signed informed consent.
- Patient's age ≥18 years at the time of signing the informed consent.
- Histologically confirmed adenocarcinoma of the colon or rectum.
- Resected (R0 or R1) and/or effectively treated metastases (all techniques allowed) of colorectal cancer within 3-10 weeks before randomization (earlier randomisation allowed if at least 3 weeks interval between intervention and treatment start is guaranteed) AND resected primary tumor (synchronous or metachronous). In cases of synchronous metastases the interval of 3-10 weeks might be calculated following the removal of the primary tumor if this intervention was the last to address all tumor lesions.
- No radiographic evidence of active metastatic disease at study entry in a CT and/or MRI scan not older than 10 weeks prior randomization. Pre-surgery/ablation images are eligible for the study if all lesions have been addressed in the interval.
- ECOG performance status 0-2.
- Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results:
- Absolute neutrophil count \>= 1.5 x 109/L (1500/µL)
- Hemoglobin ≥ 80 g/L (8 g/dL)
- Platelet count ≥ 100 x109/L (100000/µL) without transfusion
- Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST/GOT) ≤ 3.0 × ULN.
- Calculated glomerular filtration rate (GFR) according to Cockcroft-Gault formula or according to MDRD ≥ 50 mL/min or serum creatinine ≤ 1.5 x ULN
- Patients without anticoagulation need to present with an INR \< 1.5 x ULN and PTT \< 1.5 x ULN. Patient with prophylactic or therapeutic anticoagulation are allowed into the trial.
- Proficient fluorouracil metabolism as defined:
- +6 more criteria
You may not qualify if:
- Treatment of metastases greater than 3 cm with radio-frequency/microwave ablation within 24 months prior to study entry if applicable.
- Treatment of metastases greater than 5 cm with radiation (stereotactic/ brachytherapy) within 24 months prior to study entry if applicable.
- A total duration of oxaliplatin-based therapy of six months (i.e. 12 cycles of FOLFOX / FOLFOXIRI or 8 cycles CAPOX) is not exceeded - including therapy within the FIRE-9/PORT trial
- If already more than three months of oxaliplatin-based therapy (i.e. \>6 cycles of FOLFOX / FOLFOXIRI or \>4 cycles CAPOX) was used, the study therapy should be started with an irinotecan-based regimen (i.e. FOLFIRI or FOLFOXIRI) However, in the case of FOLFOXIRI therapy in the trial, the above mention regulation concerning the total dosing of oxaliplatin still applies (i.e. 12 cycles of FOLFOX / FOLFOXIRI or 8 cycles CAPOX should not be exceeded - including therapy within the FIRE-9/PORT trial).
- New York Heart Association Class III or greater heart failure by clinical judgement.
- Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization.
- Unstable angina pectoris.
- Unstable cardiac arrhythmia \> grade 2 NCI CTCAE despite anti-arrhythmic therapy.
- Ongoing toxicities \> grade 2 NCI CTCAE
- Active uncontrolled infection by investigator's perspective.
- Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture.
- Known hypersensitivity to 5-FU, folinic acid, irinotecan, oxaliplatin or capecitabine or to any of the other excipients listed in section 6.1 of the corresponding SmPC.
- Recent or concomitant treatment with brivudine.
- Peripheral sensitive neuropathy with functional impairment (\> grade 1 acc. to CTCAE version 5.0 (see appendix 2)).
- Inflammatory bowel disease and/or bowel obstruction.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Klinikum St. Marien Amberg
Amberg, Germany
Helios Klinikum Bad Saarow
Bad Saarow, Germany
Klinikum Bayreuth
Bayreuth, Germany
Charité Universitätsmedizin Berlin
Berlin, 13353, 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
Kliniken der Satdt Köln
Cologne, 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 im Breisgau, 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
Hanover, Germany
St. Anna Hospital Herne
Herne, Germany
Universitätsklinikum des Saarlandes
Homburg, Germany
Klinikum Ingolstadt GmbH
Ingolstadt, Germany
Universitätsklinikum Jena
Jena, 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
Nuremberg, 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
Related Publications (1)
Raschzok N, Stintzing S, Heinemann V, Rauch G, Ricke J, Guckenberger M, Kurreck A, Alig AHS, Stahler A, Bullinger L, Schmelzle M, Schoning W, Lurje G, Krenzien F, Haase O, Rau B, Gebauer B, Sauer IM, Pratschke J, Modest DP. FIRE-9 - PORT / AIO-KRK-0418: a prospective, randomized, open, multicenter Phase III trial to investigate the efficacy of adjuvant/additive chemotherapy in patients with definitely-treated metastatic colorectal cancer. BMC Cancer. 2022 Apr 2;22(1):359. doi: 10.1186/s12885-022-09422-6.
PMID: 35366831DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominik Modest, Prof. Dr.
Charite University, Berlin, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
August 6, 2021
First Posted
August 17, 2021
Study Start
December 6, 2021
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2030
Last Updated
December 12, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share