NCT05861505RecruitingPhase 3
COLLISION RELAPSE Trial
COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 26 Apr 2023
- Start date
- 24 Apr 2023
- Primary completion date
- 1 May 2027
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Colorectal cancer
- NCT number
- NCT05861505
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 360
- From 24 Apr 2023 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.