Background
Methods/design
Aim of the study
Sample size and follow-up
Selection of study population
Study population
Inclusion criteria
Exclusion criteria
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patients who have been disease-free for at least three years before randomization
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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
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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
Randomization
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number of treated metastases (> 2 versus 1–2)
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pretreatment with systemic therapy for metastatic colorectal cancer yes versus no pretreatment
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choice of potential therapy in the trial: (fit for mFOLFOXIRI versus fit for FOLFOX)
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presence of at least one bad prognostic factor (peritoneal metastases resected/ known BRAF mutation/ synchronous metastases defined as evidence of metastases < 12 months vs 12 + months after first diagnosis) versus no bad prognostic factor)
Primary endpoint
Secondary endpoints
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PFS in patients with/without prior systemic therapy
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PFS in patients with R1 vs R0 resected lesions as well as ablated vs. purely resected lesions
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Overall survival
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Safety
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Quality of life
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Treatments (including efficacy) beyond study participation
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PFS and OS according to circulating tumor DNA at baseline (ctDNA positive vs. negative),
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Outcome in molecular subgroups,
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Local control of lesions according to ablative technique (surgery vs. ablation vs. radiation).
Interventions and comparisons
Trial design
Experimental intervention
Drug | Dose/ Potency | Duration of administrationc | Route of Administration | Day(s) of application |
---|---|---|---|---|
mFOLFOX-6 regimen: | ||||
Oxaliplatin | 85 mg/m2 | 2 h | IV infusion | d1 of each chemotherapy cycle |
Leucovorin | 400 mg/m2 | 1-2 h | IV infusion | |
5-FUa | 400 mg/m2 bolusb 2400 mg/m2 | 2–5 min 46 h | IV infusion IV infusion | |
mFOLFOXIRI regimen: | ||||
Oxaliplatin | 85 mg/m2 | 2 h | IV infusion | d1 of each chemotherapy cycle |
Irinotecan | 150 mg/m2 | 90 min | IV infusion | |
Leucovorin | 400 mg/m2 | 1-2 h | IV infusion | |
5-FUa | 2400 mg/m2 | 46 h | IV infusion |