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COLLISION RELAPSE trial Recurrent colorectal liver metastases: repeat local treatment +/- neoadjuvant systemic therapy, a phase III prospective randomized controlled trial
EU CTIS ID: 2024-515341-41-01
What this study is testing
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).
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histological documentation of primary colorectal tumor
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: Version 3 May 12th 2023 45 of 140 o Hemoglobin ≥ 5.6 mmol/L; o Absolute neutrophil count (ANC) ≥ 1,500/mm3; o Platelet count ≥ 100*109/l; o Total bilirubin ≤ 1.5 times the upper limit of normal; o ALT and AST ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for subjects with liver involvement of their cancer); o Albumine > 30 g/l; o Serum creatinine ≤ 1.5 x upper limit of normal or a MDRD ≥ 50 ml/min; o Prothrombin time or INR < 1.5 x ULN, unless coumarin derivates are used. Due to interactions with capecitabine, all patients using coumarin derivates will be treated with LMWH instead. o Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician).
- Written informed consent
- Local treatment performed for initial CRLM
- At least one recurrent CRLM eligible for local treatment (partial hepatectomy and/or thermal ablation
You likely can't join if
- No target lesions suitable for both resection and ablation
- 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
- Microsatellite instability (MSI)
- Radical treatment unfeasible or unsafe (e.g. insufficient FLR)
- The presence of extrahepatic nodal or non-nodal metastases; see below for additional information regarding pulmonary nodules
See the full eligibility criteria
Who can join
- Histological documentation of primary colorectal tumor
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: Version 3 May 12th 2023 45 of 140 o Hemoglobin ≥ 5.6 mmol/L; o Absolute neutrophil count (ANC) ≥ 1,500/mm3; o Platelet count ≥ 100*109/l; o Total bilirubin ≤ 1.5 times the upper limit of normal; o ALT and AST ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for subjects with liver involvement of their cancer); o Albumine > 30 g/l; o Serum creatinine ≤ 1.5 x upper limit of normal or a MDRD ≥ 50 ml/min; o Prothrombin time or INR < 1.5 x ULN, unless coumarin derivates are used. Due to interactions with capecitabine, all patients using coumarin derivates will be treated with LMWH instead. o Activated partial thromboplastin time < 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician).
- Written informed consent
- Local treatment performed for initial CRLM
- At least one recurrent CRLM eligible for local treatment (partial hepatectomy and/or thermal ablation
- Maximum number of CRLM 5
- Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve
- Resectability and ablatability should be re-confirmed with full exploration for hepatic, peritoneal and regional lymph node metastases
- Age >18 years
- Eastern Cooperative Oncology Group performance status (ECOG) 0-2
- American Society of Anesthesiologists (ASA) grade 1-3
What rules you out
- No target lesions suitable for both resection and ablation
- 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
- Microsatellite instability (MSI)
- Radical treatment unfeasible or unsafe (e.g. insufficient FLR)
- The presence of extrahepatic nodal or non-nodal metastases; see below for additional information regarding pulmonary nodules
- 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. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
- Immunotherapy ≤ 6 weeks prior to the randomization
- Chemotherapy ≤ 6 weeks prior to the randomization
- Progression on both oxaliplatin and irinotecan
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.