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New treatment option for Colorectal Cancer
Official title COLLISION RELAPSE Trial
ClinicalTrials.gov ID: NCT05861505
What this study is testing
What is Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)?
Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 people
See the full eligibility 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
- 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 people
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.