What is this study studying for metastatic colorectal cancer?

This study is evaluating the effectiveness and safety of additional chemotherapy after surgery or ablation in patients with metastatic colorectal cancer. Researchers are comparing chemotherapy regimens against active follow-up to understand their impact on survival and quality of life. The study is led by Dominik Paul Modest and conducted across multiple centers.

Who may be eligible for this metastatic colorectal cancer clinical trial?

Adults aged 18 years or older with histologically confirmed metastatic colorectal cancer who have had all lesions surgically removed or ablated recently may be eligible. Participants must have good organ function and no active infections or uncontrolled medical conditions. Both men and women are eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic colorectal cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal expenses such as travel are not guaranteed to be covered and may vary. Participants should plan accordingly for any associated costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05008809

Post-resectionAblation Chemotherapy in Patients With Metastatic Colorectal Cancer Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy of Active Post-resectionAblation Therapy in Patients With Metastatic Colorectal Cancer

Led by Dominik Paul Modest · Updated on 2025-12-12

507

Participants Needed

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patient's signed informed consent.
Patient's age 18 years or older at the time of consent.
Histologically confirmed adenocarcinoma of the colon or rectum.
Resected (R0 or R1) and/or effectively treated metastases of colorectal cancer within 3-10 weeks before randomization.
Resected primary tumor (synchronous or metachronous).
Absence of significant active wound healing complications at randomization.
No radiographic evidence of active metastatic disease on recent CT or MRI scans.
ECOG performance status of 0 to 2.
Adequate bone marrow, liver, and kidney function based on specific laboratory tests.
INR less than 1.5 x ULN and PTT less than 1.5 x ULN if not on anticoagulation; patients on anticoagulation allowed.
Proficient fluorouracil metabolism demonstrated by prior treatment or testing.
For women of childbearing potential: negative pregnancy test and agreement to use effective contraception during treatment and for specified periods after.
For men with partners of childbearing potential: agreement to use effective contraception and refrain from sperm donation during treatment and specified periods after.

You will not qualify if you...

Treatment of metastases larger than 3 cm with radio-frequency/microwave ablation within 24 months prior.
Treatment of metastases larger than 5 cm with radiation within 24 months prior.
Previous oxaliplatin-containing chemotherapy exceeding specified cumulative doses.
New York Heart Association Class III or higher heart failure.
Recent myocardial infarction or percutaneous coronary intervention within 6 months.
Unstable angina or cardiac arrhythmia greater than grade 2.
Ongoing toxicities greater than grade 2.
Active uncontrolled infection.
Severe chronic wounds or untreated bone fractures.
Known hypersensitivity to study drugs or excipients.
Recent or concomitant treatment with brivudine.
Peripheral neuropathy with functional impairment greater than grade 1.
Inflammatory bowel disease or bowel obstruction.
Use of Johannis herbs preparations.
Pernicious anemia or vitamin B12 deficiency.
Recent major surgery or significant injury within 21 days prior.
Any disease or condition that contraindicates study drug use or increases risk.
History of other malignancies with specific exceptions.
Known alcohol or drug abuse.
Pregnant or breastfeeding females.
Participation in another clinical trial or experimental drug treatment within specified timeframes.
Dependence on sponsor, investigator, or study site.
Suspected COVID-19 infection.
Legal incapacity or institutionalization.
Use of strong CYP3A4 or UGT1A1 inducers.
Planned live vaccination during and up to 6 months after treatment.

Research Team

Dominik Modest, Prof. Dr.

Daniel Müller, Dr.

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