Actively Recruiting
Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
Led by Dominik Paul Modest · Updated on 2025-12-12
507
Participants Needed
79
Research Sites
464 weeks
Total Duration
On this page
Sponsors
D
Dominik Paul Modest
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed informed consent.
- Patient is 18 years or older at consent.
- Histologically confirmed adenocarcinoma of the colon or rectum.
- All metastases resected or effectively treated within 3-10 weeks before randomization.
- Primary tumor removed (synchronous or metachronous).
- No active wound healing problems at randomization; resolved complications allowed.
- No radiographic evidence of active metastatic disease on CT or MRI within 10 weeks before randomization.
- ECOG performance status of 0 to 2.
- Adequate bone marrow, liver, and kidney function based on lab tests.
- INR less than 1.5 times upper limit of normal and PTT less than 1.5 times upper limit of normal if not on anticoagulation.
- Proven fluorouracil metabolism ability or adjusted dosing if DPD deficiency is present.
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception during treatment and afterwards.
- Men with female partners of childbearing potential must use effective contraception and abstain from sperm donation during treatment and for 6 months after.
You will not qualify if you...
- Metastases larger than 3 cm treated with radio-frequency or microwave ablation within 24 months prior to study.
- Metastases larger than 5 cm treated with radiation therapy within 24 months prior to study.
- Previous oxaliplatin chemotherapy exceeding 6 months total duration.
- New York Heart Association Class III or higher heart failure.
- Myocardial infarction or certain heart procedures within 6 months prior to randomization.
- Unstable angina or cardiac arrhythmia grade higher than 2.
- Ongoing toxicities higher than grade 2.
- Active uncontrolled infection.
- Severe chronic wounds, ulcers, or untreated bone fractures.
- Known allergy to study drugs or their ingredients.
- Recent or current treatment with brivudine.
- Peripheral neuropathy with functional impairment higher than grade 1.
- Inflammatory bowel disease or bowel obstruction.
- Use of Johannis herbs preparations.
- Vitamin B12 deficiency causing anemia.
- Major surgery or trauma within 21 days prior to randomization.
- Any other condition increasing risk or affecting study results.
- History of other cancers unless disease-free for at least three years or specific exceptions.
- Known alcohol or drug abuse.
- Pregnant or breastfeeding women.
- Participation in another clinical trial or experimental treatment recently or simultaneously.
- Dependence on study sponsor or site.
- Suspected COVID-19 infection.
- Legal incapacity or commitment.
- Use of certain strong enzyme-inducing drugs.
- Planned vaccination with live vaccine during and up to 6 months after treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 79 locations
1
Klinikum St. Marien Amberg
Amberg, Germany
Actively Recruiting
2
Helios Klinikum Bad Saarow
Bad Saarow, Germany
Actively Recruiting
3
Klinikum Bayreuth
Bayreuth, Germany
Actively Recruiting
4
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
5
Helios Klinikum Emil von Behring
Berlin, Germany
Actively Recruiting
6
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany
Actively Recruiting
7
Vivantes Klinikum am Urban Berlin
Berlin, Germany
Actively Recruiting
8
Vivantes Klinikum Spandau Berlin
Berlin, Germany
Actively Recruiting
9
St. Josef-Hospital Bochum
Bochum, Germany
Actively Recruiting
10
Johanniterkrankenhaus Bonn
Bonn, Germany
Actively Recruiting
11
Diakonie-Krankenhaus Bremen
Bremen, Germany
Withdrawn
12
Klinikum Chemnitz
Chemnitz, Germany
Actively Recruiting
13
Kliniken der Satdt Köln
Cologne, Germany
Actively Recruiting
14
Klinikum Darmstadt
Darmstadt, Germany
Actively Recruiting
15
DONAUISAR Klinikum Deggendorf
Deggendorf, Germany
Actively Recruiting
16
Städtisches Klinikum Dessau
Dessau, Germany
Actively Recruiting
17
Onkologische-Gemeinschaftspraxis Dresden
Dresden, Germany
Actively Recruiting
18
Onkozentrum Dresden
Dresden, Germany
Actively Recruiting
19
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Actively Recruiting
20
Kliniken Essen-Mitte
Essen, Germany
Actively Recruiting
21
Universitätsklinikum Essen
Essen, Germany
Actively Recruiting
22
KHNW Frankfurt
Frankfurt, Germany
Actively Recruiting
23
Markus-Krankenhaus Frankfurt
Frankfurt, Germany
Actively Recruiting
24
Universitätsklinikum Frankfurt
Frankfurt, Germany
Actively Recruiting
25
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Actively Recruiting
26
Gemeinschaftspraxis internistische Onkologie Fürth
Fürth, Germany
Actively Recruiting
27
Niels-Stensen Kliniken Georgsmarienhütte
Georgsmarienhütte, Germany
Actively Recruiting
28
Praxis Hämatologie Onkologie Gießen
Giessen, Germany
Actively Recruiting
29
Universitätsmedizin Göttingen
Göttingen, Germany
Actively Recruiting
30
Universitätsklinikum Halle
Halle, Germany
Actively Recruiting
31
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
32
Medizinische Hochschule Hannover
Hanover, Germany
Actively Recruiting
33
St. Anna Hospital Herne
Herne, Germany
Actively Recruiting
34
Universitätsklinikum des Saarlandes
Homburg, Germany
Actively Recruiting
35
Klinikum Ingolstadt GmbH
Ingolstadt, Germany
Withdrawn
36
Universitätsklinikum Jena
Jena, Germany
Actively Recruiting
37
Klinikum Landshut
Landshut, Germany
Actively Recruiting
38
VK&K Studien Landshut
Landshut, Germany
Actively Recruiting
39
Studienzentrum UnterEms Leer
Leer, Germany
Active, Not Recruiting
40
Universitätsklinikum Leipzig
Leipzig, Germany
Actively Recruiting
41
Klinikum Leverkusen
Leverkusen, Germany
Actively Recruiting
42
Klinikum Lippe
Lippe, Germany
Actively Recruiting
43
Klinikum Ludwigsburg
Ludwigsburg, Germany
Actively Recruiting
44
Klinikum Magdeburg
Magdeburg, Germany
Actively Recruiting
45
Universitätsmedizin Mainz
Mainz, Germany
Actively Recruiting
46
OnkoNet Marburg GmbH
Marburg, Germany
Actively Recruiting
47
Philipps-Universität Marburg
Marburg, Germany
Actively Recruiting
48
Johannes Wesling Klinikum Minden
Minden, Germany
Actively Recruiting
49
Kliniken Maria Hilf Mönchengladbach
Mönchengladbach, Germany
Withdrawn
50
Klinikum der Universität München
München, Germany
Actively Recruiting
51
Klinikum rechts der Isar TU München
München, Germany
Actively Recruiting
52
München Klinik Bogenhausen
München, Germany
Actively Recruiting
53
München Klinik Neuperlach
München, Germany
Actively Recruiting
54
Gemeinschaftspraxis Münster
Münster, Germany
Actively Recruiting
55
Universitätsklinikum Münster
Münster, Germany
Actively Recruiting
56
Friedrich-Ebert-Krankenhaus Neumünster
Neumünster, Germany
Actively Recruiting
57
Lukaskrankenhaus Neuss
Neuss, Germany
Actively Recruiting
58
Klinikum Nürnberg
Nuremberg, Germany
Actively Recruiting
59
Pi.Tri-Studien GmbH Offenburg
Offenburg, Germany
Withdrawn
60
Klinikum Passau
Passau, Germany
Actively Recruiting
61
Schwerpunktpraxis Penzberg
Penzberg, Germany
Actively Recruiting
62
Ernst von Bergmann Klinikum Potsdam
Potsdam, Germany
Actively Recruiting
63
Studienzentrum Onkologie Ravensburg
Ravensburg, Germany
Actively Recruiting
64
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Germany
Actively Recruiting
65
Universitätsklinikum Regensburg
Regensburg, Germany
Actively Recruiting
66
Kreiskliniken Reutlingen
Reutlingen, Germany
Actively Recruiting
67
Mathias Spital Rheine
Rheine, Germany
Actively Recruiting
68
RoMed Klinikum Rosenheim
Rosenheim, Germany
Actively Recruiting
69
Universitätsmedizin Rostock
Rostock, Germany
Actively Recruiting
70
DIAK Klinikum Schwäbisch Hall
Schwäbisch Hall, Germany
Actively Recruiting
71
Marienkrankenhaus Siegen
Siegen, Germany
Actively Recruiting
72
Klinikum Stuttgart
Stuttgart, Germany
Actively Recruiting
73
Marienhospital Stuttgart
Stuttgart, Germany
Withdrawn
74
Krankenhaus der Barmherzigen Brüder Trier
Trier, Germany
Actively Recruiting
75
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
76
Klinikum Wetzlar
Wetzlar, Germany
Actively Recruiting
77
Onkologisches Zentrum Wolfsburg-Helmstedt
Wolfsburg, Germany
Withdrawn
78
Petrus-Krankenhaus Wuppertal
Wuppertal, Germany
Actively Recruiting
79
Gemeinschaftspraxis Würzburg
Würzburg, Germany
Actively Recruiting
Research Team
D
Dominik Modest, Prof. Dr.
CONTACT
D
Daniel Müller, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here