Chemo after surgery may delay return of advanced colon cancer

NCT ID NCT05008809

Disease control Sponsor: Dominik Paul Modest Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether giving chemotherapy after all visible tumors have been removed or destroyed can delay cancer progression in people with metastatic colorectal cancer. About 507 participants will be randomly assigned to receive either chemotherapy (mFOLFOX6 or mFOLFOXIRI) or active surveillance (no treatment). The goal is to see if the chemo improves how long the cancer stays away.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: chemotherapy (mFOLFOX6 or mFOLFOXIRI)
What this could lead to: If it works, this could show that giving chemotherapy after removing all visible tumors helps keep the cancer from coming back longer than just watching and waiting.
What could go wrong: This is a large Phase 3 trial, but chemotherapy has significant side effects, and it is not yet known if the benefits outweigh the risks compared to surveillance alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 507 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient's signed informed consent. 2. Patient's age ≥18 years at the time of signing the informed consent. 3. Histologically confirmed adenocarcinoma of the colon or rectum. 4. 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. 5. 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. 6. 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. 7. ECOG performance status 0-2. 8. 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 9. 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. 10. Proficient fluorouracil metabolism as defined: 1. Prior treatment with 5-FU or capecitabine without unusual toxicity or 2. If tested, normal DPD deficiency test according to the standard of the study site or 3. 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% 11. 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. Exclusion Criteria: 1. Treatment of metastases greater than 3 cm with radio-frequency/microwave ablation within 24 months prior to study entry if applicable. 2. Treatment of metastases greater than 5 cm with radiation (stereotactic/ brachytherapy) within 24 months prior to study entry if applicable. 3. 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 1. 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 2. 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). 4. New York Heart Association Class III or greater heart failure by clinical judgement. 5. Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization. 6. Unstable angina pectoris. 7. Unstable cardiac arrhythmia \> grade 2 NCI CTCAE despite anti-arrhythmic therapy. 8. Ongoing toxicities \> grade 2 NCI CTCAE 9. Active uncontrolled infection by investigator's perspective. 10. Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture. 11. 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. 12. Recent or concomitant treatment with brivudine. 13. Peripheral sensitive neuropathy with functional impairment (\> grade 1 acc. to CTCAE version 5.0 (see appendix 2)). 14. Inflammatory bowel disease and/or bowel obstruction. 15. Simultaneous application of Johannis herbs preparations. 16. Pernicious or other megaloblastic anemia caused by vitamin B12 deficiency. 17. 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. 18. 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. 19. 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 20. Known alcohol or drug abuse. 21. Pregnant or breastfeeding females. 22. 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. 23. Patients depending on Sponsor, investigator or study site. 24. 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. 25. Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 26. Limited legal capacity. 27. Concomitant administration of strong CYP3A4 and/or UGT1A1 inducers (e.g. Rifampicin, Carbamazepin, Phenobarbital, Phenytoin or Apalutamid). 28. Planned inoculation/vaccination with a live vaccine during treatment with Oxaliplatin and/or Irinotecan, and until 6 months after treatment with Irinotecan.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

72 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Charité Universitätsmedizin Berlin
RECRUITING

Berlin, 13353, Germany
DIAK Klinikum Schwäbisch Hall
RECRUITING

Schwäbisch Hall, Germany
DONAUISAR Klinikum Deggendorf
RECRUITING

Deggendorf, Germany
Diakonie-Krankenhaus Bremen
WITHDRAWN

Bremen, Germany
Ernst von Bergmann Klinikum Potsdam
RECRUITING

Potsdam, Germany
Friedrich-Ebert-Krankenhaus Neumünster
RECRUITING

Neumünster, Germany
Gemeinschaftspraxis Münster
RECRUITING

Münster, Germany
Gemeinschaftspraxis Würzburg
RECRUITING

Würzburg, Germany
Gemeinschaftspraxis internistische Onkologie Fürth
RECRUITING

Fürth, Germany
Helios Klinikum Bad Saarow
RECRUITING

Bad Saarow, Germany
Helios Klinikum Emil von Behring
RECRUITING

Berlin, Germany
Johannes Wesling Klinikum Minden
RECRUITING

Minden, Germany
Johanniterkrankenhaus Bonn
RECRUITING

Bonn, Germany
KHNW Frankfurt
RECRUITING

Frankfurt, Germany
Kliniken Essen-Mitte
RECRUITING

Essen, Germany
Kliniken Maria Hilf Mönchengladbach
WITHDRAWN

Mönchengladbach, Germany
Kliniken der Satdt Köln
RECRUITING

Cologne, Germany
Klinikum Bayreuth
RECRUITING

Bayreuth, Germany
Klinikum Chemnitz
RECRUITING

Chemnitz, Germany
Klinikum Darmstadt
RECRUITING

Darmstadt, Germany
Klinikum Ingolstadt GmbH
WITHDRAWN

Ingolstadt, Germany
Klinikum Landshut
RECRUITING

Landshut, Germany
Klinikum Leverkusen
RECRUITING

Leverkusen, Germany
Klinikum Lippe
RECRUITING

Lippe, Germany
Klinikum Ludwigsburg
RECRUITING

Ludwigsburg, Germany
Klinikum Magdeburg
RECRUITING

Magdeburg, Germany
Klinikum Nürnberg
RECRUITING

Nuremberg, Germany
Klinikum Passau
RECRUITING

Passau, Germany
Klinikum St. Marien Amberg
RECRUITING

Amberg, Germany
Klinikum Stuttgart
RECRUITING

Stuttgart, Germany
Klinikum Wetzlar
RECRUITING

Wetzlar, Germany
Klinikum der Universität München
RECRUITING

München, Germany
Klinikum rechts der Isar TU München
RECRUITING

München, Germany
Krankenhaus Barmherzige Brüder Regensburg
RECRUITING

Regensburg, Germany
Krankenhaus der Barmherzigen Brüder Trier
RECRUITING

Trier, Germany
Kreiskliniken Reutlingen
RECRUITING

Reutlingen, Germany
Lukaskrankenhaus Neuss
RECRUITING

Neuss, Germany
MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim
RECRUITING

Berlin, Germany
Marienhospital Stuttgart
WITHDRAWN

Stuttgart, Germany
Marienkrankenhaus Siegen
RECRUITING

Siegen, Germany
Markus-Krankenhaus Frankfurt
RECRUITING

Frankfurt, Germany
Mathias Spital Rheine
RECRUITING

Rheine, Germany
Medizinische Hochschule Hannover
RECRUITING

Hanover, Germany
München Klinik Bogenhausen
RECRUITING

München, Germany
München Klinik Neuperlach
RECRUITING

München, Germany
Niels-Stensen Kliniken Georgsmarienhütte
RECRUITING

Georgsmarienhütte, Germany
OnkoNet Marburg GmbH
RECRUITING

Marburg, Germany
Onkologische-Gemeinschaftspraxis Dresden
RECRUITING

Dresden, Germany
Onkologisches Zentrum Wolfsburg-Helmstedt
WITHDRAWN

Wolfsburg, Germany
Onkozentrum Dresden
RECRUITING

Dresden, Germany
Petrus-Krankenhaus Wuppertal
RECRUITING

Wuppertal, Germany
Philipps-Universität Marburg
RECRUITING

Marburg, Germany
Pi.Tri-Studien GmbH Offenburg
WITHDRAWN

Offenburg, Germany
Praxis Hämatologie Onkologie Gießen
RECRUITING

Giessen, Germany
RoMed Klinikum Rosenheim
RECRUITING

Rosenheim, Germany
Schwerpunktpraxis Penzberg
RECRUITING

Penzberg, Germany
St. Anna Hospital Herne
RECRUITING

Herne, Germany
St. Josef-Hospital Bochum
RECRUITING

Bochum, Germany
Studienzentrum Onkologie Ravensburg
RECRUITING

Ravensburg, Germany
Studienzentrum UnterEms Leer
ACTIVE_NOT_RECRUITING

Leer, Germany
Städtisches Klinikum Dessau
RECRUITING

Dessau, Germany
Universitätsklinikum Düsseldorf
RECRUITING

Düsseldorf, Germany
Universitätsklinikum Essen
RECRUITING

Essen, Germany
Universitätsklinikum Frankfurt
RECRUITING

Frankfurt, Germany
Universitätsklinikum Freiburg
RECRUITING

Freiburg im Breisgau, Germany
Universitätsklinikum Halle
RECRUITING

Halle, Germany
Universitätsklinikum Hamburg-Eppendorf
RECRUITING

Hamburg, Germany
Universitätsklinikum Jena
RECRUITING

Jena, Germany
Universitätsklinikum Leipzig
RECRUITING

Leipzig, Germany
Universitätsklinikum Münster
RECRUITING

Münster, Germany
Universitätsklinikum Regensburg
RECRUITING

Regensburg, Germany
Universitätsklinikum Ulm
RECRUITING

Ulm, Germany
Universitätsklinikum des Saarlandes
RECRUITING

Homburg, Germany
Universitätsmedizin Göttingen
RECRUITING

Göttingen, Germany
Universitätsmedizin Mainz
RECRUITING

Mainz, Germany
Universitätsmedizin Rostock
RECRUITING

Rostock, Germany
VK&K Studien Landshut
RECRUITING

Landshut, Germany
Vivantes Klinikum Spandau Berlin
RECRUITING

Berlin, Germany
Vivantes Klinikum am Urban Berlin
RECRUITING

Berlin, Germany

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