Actively Recruiting
Led by Amsterdam UMC, location VUmc · Updated on 2023-05-17
360
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating treatment options for patients with recurrent colorectal liver metastases (CRLM) who have at least one locally treatable recurrence within 12 months after initial local treatment and no cancer outside the liver. The study aims to compare whether giving neoadjuvant systemic therapy before repeat local treatment improves overall survival compared to repeat local treatment alone. This phase III randomized controlled trial enrolls patients with good health status and considers specific tumor and genetic factors for grouping before treatment. Participants are randomly assigned to one of two groups: the control group receives upfront repeat local treatment, while the intervention group receives 12 weeks of neoadjuvant systemic therapy followed by repeat local treatment. The systemic therapy includes up to 4 cycles of CAPOX or 6 cycles of FOLFOX/FOLFIRI chemotherapy, possibly combined with bevacizumab. The choice of repeat local treatment, such as surgery or thermal ablation, is decided by local doctors based on each patient's situation. During the study, patients will be monitored for up to 5 years, with assessments including overall survival, progression-free survival, treatment side effects, hospital stay length, pain levels, quality of life, and cost-effectiveness. Researchers will collect clinical data and evaluate safety outcomes after treatments. The total participation time includes treatment and long-term follow-up to understand the effects of these treatment approaches on patient outcomes.
CONDITIONS
COLLISION RELAPSE Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants randomized to this group receive up to 12 weeks of neoadjuvant systemic therapy with chemotherapy regimens such as CAPOX, FOLFOX, or FOLFIRI, with or without bevacizumab.
Cycles administered over this period as per chemotherapy schedule
Duration - Duration of procedure and immediate recovery
Participants undergo repeat local treatment for recurrent colorectal liver metastases. The choice of surgical resection and/or thermal ablation is made by the local investigator based on individual patient needs.
1 treatment visit (in-person)
Duration - Duration of procedure and immediate recovery
Participants randomized to upfront treatment receive repeat local treatment for recurrent colorectal liver metastases. The choice of surgical resection and/or thermal ablation is made by the local investigator based on individual patient needs.
1 treatment visit (in-person)
Duration - Up to 5 years
Participants are monitored for survival, disease progression, and treatment-related outcomes for up to 5 years after treatment.
Regular follow-up visits over 5 years
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
M
M Dijkstra
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Madelon Dijkstra, Babette I Kuiper, Hannah H Schulz...
https://pubmed.ncbi.nlm.nih.gov/37943351