AzTrials
AzTrials

Colorectal CancerPhase 3NCT05008809

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

A Phase 3 study testing mFOLFOX6, mFOLFOXIRI and FOLFIRI in people with Colorectal Cancer, run by Dominik Paul Modest at 79 sites in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
mFOLFOX6, mFOLFOXIRI and FOLFIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
507 participants
Where
79 sitesGermany
Study dates
6 Dec 2021to Nov 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Absence of significant active wound healing complications (if applicable) at randomization. Resolved wound healing complications after resection/ablation are acceptable for inclusion into the trial.
  • 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.
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  • 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:
  • Prior treatment with 5-FU or capecitabine without unusual toxicity or
  • If tested, normal DPD deficiency test according to the standard of the study site or
  • If tested, in patients with DPD deficiency test with a CPIC activity score of 1.0-1.5 fluoropyrimidine/capecitabine dosage should be reduced by 50%
  • For women of childbearing potential (WOCBP): negative pregnancy test within 14 days before randomization and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 9 months after the last dose of Oxaliplatin or for at least 6 months after the last dose of all other study treatment.
  • A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male partner's sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • For men: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same period.

Who cannot join

  • 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.
  • Any previous systemic therapy is allowed for inclusion into the trial. However, if previous oxaliplatin-containing chemotherapy at any time for metastatic or localized disease was carried out, the inclusion into the trial is permitted under the condition, that
  • 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.
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  • 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.
  • Simultaneous application of Johannis herbs preparations.
  • Pernicious or other megaloblastic anemia caused by vitamin B12 deficiency.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to randomization or at least to intended treatment start, or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
  • Medical history of malignant disease other than mCRC with the following exceptions:
  • patients who have been disease-free for at least three years before randomization
  • patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer
  • patients with any treated or untreated malignant disease that is associated with a 5-year survival prognosis of ≥ 90% and does not require active therapy
  • Known alcohol or drug abuse.
  • Pregnant or breastfeeding females.
  • Participation in a clinical trial or experimental drug treatment within 28 days prior to potential inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to potential inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial.
  • Patients depending on Sponsor, investigator or study site.
  • Suspected SARS-CoV-2 infection with or without symptoms (evaluation according to local policy in respective center with respect to actual status of pandemic and with reference to the policy that would apply to patients with similar therapy outside the trial). This may include assessment of vaccination status, anamnesis, physical examination and potentially antigen and/or PCR testing.
  • Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Limited legal capacity.
  • Concomitant administration of strong CYP3A4 and/or UGT1A1 inducers (e.g. Rifampicin, Carbamazepin, Phenobarbital, Phenytoin or Apalutamid).
  • Planned inoculation/vaccination with a live vaccine during treatment with Oxaliplatin and/or Irinotecan, and until 6 months after treatment with Irinotecan.

Trial locations and contacts

79 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dominik Modest, Prof. Dr. contact

+49 30 450 ext. 553222

dominik.modest@charite.de

Daniel Müller, Dr. contact

+49 69 7601 ext. 125

mueller.daniel@ikf-khnw.de

79 sites in 1 country

Germany79 sites, 72 recruiting

  • Klinikum St. Marien Amberg

    Amberg

    Ludwig Fischer von Weikersthal, Dr.

    Recruiting

  • Helios Klinikum Bad Saarow

    Bad Saarow

    Daniel Pink, Dr.

    Recruiting

  • Klinikum Bayreuth

    Bayreuth

    Alexander Kiani, Prof. Dr.

    Recruiting

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

    Dominik Modest, Prof. Dr., +49 30 450 ext. 553222, dominik.modest@charite.de

    Recruiting

  • Helios Klinikum Emil von Behring

    Berlin

    Börge Arndt, Dr.

    Recruiting

  • MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

    Berlin

    Markus Schuler, Dr.

    Recruiting

  • Vivantes Klinikum am Urban Berlin

    Berlin

    Annette Dieing, Dr.

    Recruiting

  • Vivantes Klinikum Spandau Berlin

    Berlin

    Jörg-Christian Rath, Dr.

    Recruiting

  • St. Josef-Hospital Bochum

    Bochum

    Anke Reinacher-Schick, Prof. Dr.

    Recruiting

  • Johanniterkrankenhaus Bonn

    Bonn

    Yon-Dschun Ko, Prof. Dr.

    Recruiting

  • Diakonie-Krankenhaus Bremen

    Bremen

    Withdrawn

  • Klinikum Chemnitz

    Chemnitz

    Jack Chater, Dr.

    Recruiting

  • Kliniken der Satdt Köln

    Cologne

    Bernhard Sibbing, Dr.

    Recruiting

  • Klinikum Darmstadt

    Darmstadt

    Carl Schimanski, Prof. Dr.

    Recruiting

  • DONAUISAR Klinikum Deggendorf

    Deggendorf

    Christian Spoer, Dr.

    Recruiting

  • Städtisches Klinikum Dessau

    Dessau

    Gerhard Behre, Prof. Dr.

    Recruiting

  • Onkologische-Gemeinschaftspraxis Dresden

    Dresden

    Lutz Jacobasch, Dr.

    Recruiting

  • Onkozentrum Dresden

    Dresden

    Steffen Dörfel

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf

    Christoph Roderburg, Prof. Dr.

    Recruiting

  • Kliniken Essen-Mitte

    Essen

    Christian Müller, Dr.

    Recruiting

  • Universitätsklinikum Essen

    Essen

    Stefan Kasper-Virchow, Prof. Dr.

    Recruiting

  • KHNW Frankfurt

    Frankfurt

    Thorsten Götze, PD Dr.

    Recruiting

  • Markus-Krankenhaus Frankfurt

    Frankfurt

    Silvan Becker, Dr.

    Recruiting

  • Universitätsklinikum Frankfurt

    Frankfurt

    Christine Koch, Dr.

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

    Michael Quante, Prof. Dr.

    Recruiting

  • Gemeinschaftspraxis internistische Onkologie Fürth

    Fürth

    Jochen Wilke, Dr.

    Recruiting

  • Niels-Stensen Kliniken Georgsmarienhütte

    Georgsmarienhütte

    Jens Atzpodien, Prof. Dr.

    Recruiting

  • Praxis Hämatologie Onkologie Gießen

    Giessen

    Georg Schließer, Dr.

    Recruiting

  • Universitätsmedizin Göttingen

    Göttingen

    Yong-Jun Peter Jo, Dr.

    Recruiting

  • Universitätsklinikum Halle

    Halle

    Mascha Binder, Prof. Dr.

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Marianne Sinn, PD Dr.

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover

    Arndt Vogel, Prof. Dr.

    Recruiting

  • St. Anna Hospital Herne

    Herne

    Vera Heuer, Dr.

    Recruiting

  • Universitätsklinikum des Saarlandes

    Homburg

    Matthias Glanemann, Prof. Dr.

    Recruiting

  • Klinikum Ingolstadt GmbH

    Ingolstadt

    Withdrawn

  • Universitätsklinikum Jena

    Jena

    Udo Lindig, Dr.

    Recruiting

  • Klinikum Landshut

    Landshut

    Christian Bogner, Dr.

    Recruiting

  • VK&K Studien Landshut

    Landshut

    Florian Kaiser, Dr.

    Recruiting

  • Studienzentrum UnterEms Leer

    Leer

    Active, not recruiting

  • Universitätsklinikum Leipzig

    Leipzig

    Ulrich Hacker, Prof. Dr.

    Recruiting

  • Klinikum Leverkusen

    Leverkusen

    Andrea Heider, Dr.

    Recruiting

  • Klinikum Lippe

    Lippe

    Christian Constantin, Dr.

    Recruiting

  • Klinikum Ludwigsburg

    Ludwigsburg

    Stefan Angermeier, Dr.

    Recruiting

  • Klinikum Magdeburg

    Magdeburg

    Christoph Kahl, Prof. Dr.

    Recruiting

  • Universitätsmedizin Mainz

    Mainz

    Markus Möhler, Prof. Dr.

    Recruiting

  • OnkoNet Marburg GmbH

    Marburg

    Christina Balser, Dr.

    Recruiting

  • Philipps-Universität Marburg

    Marburg

    Jorge Riera, Dr.

    Recruiting

  • Johannes Wesling Klinikum Minden

    Minden

    Hans-Joachim Tischler, Dr.

    Recruiting

  • Kliniken Maria Hilf Mönchengladbach

    Mönchengladbach

    Withdrawn

  • Klinikum der Universität München

    München

    Victoria Probst, Dr.

    Recruiting

  • Klinikum rechts der Isar TU München

    München

    Sylvie Lorenzen, Prof. Dr.

    Recruiting

  • München Klinik Bogenhausen

    München

    Martin Fuchs, Dr.

    Recruiting

  • München Klinik Neuperlach

    München

    Meinolf Karthaus, Prof. Dr.

    Recruiting

  • Gemeinschaftspraxis Münster

    Münster

    Christian Lerchenmüller, Dr.

    Recruiting

  • Universitätsklinikum Münster

    Münster

    Klaus Wethmar, Dr. Dr.

    Recruiting

  • Friedrich-Ebert-Krankenhaus Neumünster

    Neumünster

    Siegfried Haas, Dr.

    Recruiting

  • Lukaskrankenhaus Neuss

    Neuss

    Ulf Reinhart, Dr.

    Recruiting

  • Klinikum Nürnberg

    Nuremberg

    Gabriele Siegler, Dr.

    Recruiting

  • Pi.Tri-Studien GmbH Offenburg

    Offenburg

    Withdrawn

  • Klinikum Passau

    Passau

    Thomas Südhoff, Prof. Dr.

    Recruiting

  • Schwerpunktpraxis Penzberg

    Penzberg

    Michael Sandherr, PD Dr.

    Recruiting

  • Ernst von Bergmann Klinikum Potsdam

    Potsdam

    Matthias Paland, Dr.

    Recruiting

  • Studienzentrum Onkologie Ravensburg

    Ravensburg

    Tobias Dechow, Prof. Dr.

    Recruiting

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg

    Anke Schlenska-Lange, Dr.

    Recruiting

  • Universitätsklinikum Regensburg

    Regensburg

    Hans Jürgen Schlitt, Prof. Dr.

    Recruiting

  • Kreiskliniken Reutlingen

    Reutlingen

    Stefan Kubicka, Prof. Dr.

    Recruiting

  • Mathias Spital Rheine

    Rheine

    Sebastian Bröckling, Dr.

    Recruiting

  • RoMed Klinikum Rosenheim

    Rosenheim

    Gerhard Gerhard Puchtler, Dr.

    Recruiting

  • Universitätsmedizin Rostock

    Rostock

    Ulrich Langenkamp, Dr.

    Recruiting

  • DIAK Klinikum Schwäbisch Hall

    Schwäbisch Hall

    Thomas Geer, Dr.

    Recruiting

  • Marienkrankenhaus Siegen

    Siegen

    Elisabeth Mack, Dr.

    Recruiting

  • Klinikum Stuttgart

    Stuttgart

    Wolfram Bohle, Dr.

    Recruiting

  • Marienhospital Stuttgart

    Stuttgart

    Withdrawn

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier

    Iordanis Deligiannis, Dr.

    Recruiting

  • Universitätsklinikum Ulm

    Ulm

    Thomas J. Ettrich, Dr.

    Recruiting

  • Klinikum Wetzlar

    Wetzlar

    Birgitta Killing, Dr.

    Recruiting

  • Onkologisches Zentrum Wolfsburg-Helmstedt

    Wolfsburg

    Withdrawn

  • Petrus-Krankenhaus Wuppertal

    Wuppertal

    Matthias Sandmann, Dr.

    Recruiting

  • Gemeinschaftspraxis Würzburg

    Würzburg

    Björn Schöttker, Dr.

    Recruiting

Other trials in Germany

About this study

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

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).

Read the 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.

Being tested
mFOLFOX6, mFOLFOXIRI, FOLFIRI, CAPOX
Keywords
Colorectal Cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mFOLFOX6Drug

    Also called Folinic acid, Oxaliplatin, 5-fluorouracil (FU)

    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.

  • mFOLFOXIRIDrug

    Also called Folinic acid, Oxaliplatin, 5-FU, Irinotecan

    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.

  • FOLFIRIDrug

    Also called Folinic acid, 5-FU

    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.

  • CAPOXDrug

    Also called Capecitaine, Oxaliplatin

    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.

Study groups in NCT05008809
Study groupRoleWhat they receive
TreatmentExperimentalActive 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
Receives: Drug: mFOLFOX6; Drug: mFOLFOXIRI; Drug: FOLFIRI; Drug: CAPOX
ControlNo interventionStructured Follow-up for up to five years after randomization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) time

    time from randomization to death or evidence of disease relapse/progression (whatever occurs first)

    Measured: 24 months

Secondary outcomes (4)

  1. Overall survival (OS)

    time from randomization to the date of death of any cause

    Measured: at least 5 years after randomization

  2. Control ol lesions

    Local or distant control of lesions according to ablative technique (surgery vs. ablation vs. radiation)

    Measured: up to 5 years after randomization

  3. (Serious) Adverse Events

    Type, incidence, severity, and causal relationship to active chemotherapy of non-serious adverse events and serious adverse events (severity evaluated according to CTCAE version 5.0)

    Measured: up to 2 years after randomization

  4. Quality of life (QoL)

    Quality of life (QoL) as assessed with the QoL questionnaire EQ-5D-5L

    Measured: up to 5 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start6 Dec 2021
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
open-label, randomized, controlled, multicenter, phase III study with two parallel arms
Masking
None (open label)
Enrolment
507 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008809
Sponsor's protocol ID
FIRE-9 - PORT
Other IDs
AIO-KRK-0418, 2020-006144-18
Status last verified
Dec 2025
First submitted
6 Aug 2021
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35366831

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing mFOLFOX6, mFOLFOXIRI and FOLFIRI in people with Colorectal Cancer, run by Dominik Paul Modest at 79 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dominik Modest, Prof. Dr. (+49 30 450 ext. 553222, dominik.modest@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) time (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05008809, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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