Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B): Standard first line systemic treatment:
CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B
CAPOX 4x (12 weeks) FOLFOX/FOLFIRI 6x (12 weeks)
Maximum 4 cycles of CAPOX or 6 cycles of FOLFOX/FOLFIRI +/- bevacizumab regardless of the location of primary tumor or RAS/BRAF mutation
Repeat local treatment: Choice of repeat local treatment is to the discretion of the local investigator, and may be selected on a per patient basis.
The safety, feasibility and preferred type of surgical resection(s) is at the discretion of the liver surgeon (whether or not combined with thermal ablation).
The safety, feasibility and preferred type of thermal ablation(s) is at the discretion of the interventional radiologist (whether or not combined with surgical resection).
Study summary
The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to upfront repeat local treatment in patients with at least one locally treatable recurrent CRLM in the absence of extrahepatic disease.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria
* Age \>18 years
* Good performance status (ECOG 0-2 // ASA 1-3)
* Histological documentation of primary colorectal tumor
* Local treatment performed for initial CRLM
* New recurrence ≤12 months
* ≥1 locally treatable CRLM (resectable\* and/or ablatable)
* Total number of new CRLM ≤5
* Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and renal function
* Written informed consent Exclusion criteria
* Extrahepatic disease
* MSI/dMMR
* Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume)
* Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites)
* Uncontrolled infections (\> grade 2 NCI-CTC version 3.0)
* Pregnant or breast-feeding subjects
* Immuno- or chemotherapy ≤ 6 weeks prior to the randomization
* Severe allergy to contrast media not controlled with premedication
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
ECOG = Eastern Cooperative Oncology Group, ASA = American Society of Anesthesiologists, MSI = Microsatellite instability, dMMR = deficient mismatch repair
\* Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve
Primary outcome measure(s)
Overall survival (OS) per patient — 5 years Primary objective is to compare overall survival (OS) in both study arms, counting from the date of randomization to the date of death of the patient or to the last day of follow-up (censored).
Trial sites (1)
Facility
City
Region
Status
Amsterdam UMC
Amsterdam
Netherlands
Recruiting
More Amsterdam UMC, location VUmc trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.