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Colorectal CancerPhase 3NCT05861505

COLLISION RELAPSE Trial

A Phase 3 study testing Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) and Repeat local treatment in people with Colorectal Cancer and Liver Metastases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) and Repeat local treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteNetherlands
Study dates
24 Apr 2023to 1 May 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 22Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

M Dijkstra contact

+31(0)204444444

interventieradiologie@vumc.nl

Netherlands1 site, 1 recruiting

  • Amsterdam UMC

    Amsterdam

    M Dijkstra, +31(0)204444444, interventieradiologie@vumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial

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.

Read the detailed description

Study design: The COLLISION RELAPSE trial is a prospective multicenter phase III randomized controlled trial. The primary conducting center will be the Amsterdam UMC (Amsterdam, the Netherlands). We hypothesize that neoadjuvant systemic therapy followed by repeat local treatment is superior to upfront repeat local treatment for the selected patient groups in terms of the primary objective (OS). The Cox proportional hazards model (1-sided; superiority) and the PASKWIL criteria for adjuvant treatment for the benefit of OS from the Dutch Society of Medical Oncology are used for the sample size calculations. A total number of 360 patients will be randomized (NR) into one of two arms: arm A (control group) upfront repeat local treatment (n=180) and arm B (intervention group) 12 weeks of neoadjuvant systemic therapy followed by repeat local treatment (n=180).

Study population: Patients with a maximum of 5 recurrent new locally treatable CRLM within 12 months after initial curative intent local treatment of CRLM, no extrahepatic disease, and a good performance status (ECOG 0-2) are considered eligible. Both chemo-naïve patients and patients who did not progress on either oxaliplatin or irinotecan chemotherapy prior to the initial local treatment are eligible for inclusion.

Eligible patients will be stratified before randomization into two groups depending on the interval between initial local treatment and first detection of recurrent CRLM: recurrence within 6 months and recurrence between 6 and 12 months, RAS/BRAF mutation vs RAS/BRAF wildtype, prognostic risk score (low vs high risk, clinical risk score Fong et al. (83)) and previous chemotherapy versus no previous chemotherapy.

Intervention: Eligible patients will be randomized into one of two arms: arm A (control group) upfront repeat local treatment and arm B (intervention group) 12 weeks of neoadjuvant systemic therapy followed by repeat local treatment. Patients in arm B will receive maximum 4 cycles of CAPOX or 6 cycles of FOLFOX/FOLFIRI +/- bevacizumab regardless of the location of primary tumor or RAS/BRAF mutation. Choice of repeat local treatment is to the discretion of the local investigator, and may be selected on a per patient basis.

Being tested
Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B), Repeat local treatment
Medical subject headings
Colorectal Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)Drug

    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 treatmentOther

    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 groups in NCT05861505
Study groupRoleWhat they receive
Upfront repeat local treatmentActive comparatorNot described
Receives: Other: Repeat local treatment
Neoadjuvant systemic therapy followed by repeat local treatmentExperimentalNot described
Receives: Drug: Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B); Other: Repeat local treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS) per patient

    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).

    Measured: 5 years

Secondary outcomes (9)

  1. Distant progression-free survival (DPFS) per patient

    Distant progression free survival (DPFS; per patient analysis): Overall DPFS is defined as the time from randomization to the time of disease progression (according to the RECIST 1.1 guideline) or cancer related death (events), death related to other causes is considered a competing risk

    Measured: 5 years

  2. Local tumor progression-free survival (LTPFS) per patient and per tumor treated

    Local tumor progression free survival (LTPFS; per tumor and per patient analysis): Overall LTPFS is defined as the time from randomization to the time of local disease progression, new metastases (events), censoring the date of death from any cause (competing risk), completion ablations performed within 6 weeks for residual tumor are not considered events for the local tumor progression analysis

    Measured: 5 years

  3. Systemic therapy related toxicity per patient following neoadjuvant systemic therapy

    Systemic therapy related toxicity is graded from 1 to 5 according to the CTCAE version 5.0

    Measured: 5 years

  4. Procedural morbidity and mortality per patient following repeat local treatment

    Procedural morbidity and mortality are graded from I to V according to the standard classification of surgical complications

    Measured: 5 years

  5. Length of hospital stay per patient following repeat local treatment

    In days

    Measured: 5 years

  6. Assessment of pain per patient

    • Pain assessment using visual analogue scale questionnaires (VAS; per procedure analysis: Assessed prior to, directly after and every three months after local treatment;

    Measured: 5 years

  7. Quality of life (QoL) per patient

    • To determine quality of life in both treatment arms. Quality of life assessment using EORCT QLQ-C30, EQ-5D, and PRODISQ questionnaires (per procedure analysis): Assessed prior to, and every three months after local treatment, assessed prior to, during and after neoadjuvant systemic therapy

    Measured: 5 years

  8. Quality-adjusted life years (QALY) per patient

    • Quality-adjusted life years (QALY) per treatment arm (per patient analysis).

    Measured: 5 years

  9. Cost-effectiveness ratio (ICER)

    • Direct and indirect total costs of care per treatment arm, and incremental cost-effectiveness ratio (ICER)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start24 Apr 2023
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05861505
Sponsor's protocol ID
NL78220.029.21
Status last verified
May 2023
First submitted
26 Apr 2023
Last updated
17 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dijkstra M, Kuiper BI, Schulz HH, van der Lei S, Puijk RS, Vos DJW, Timmer FEF, Scheffer HJ, Buffart TE, van den Tol MP, Lissenberg-Witte BI, Swijnenburg RJ, Versteeg KS, Meijerink MR; COLLISION Trial Group. Recurrent Colorectal Liver Metastases: Upfront Local Treatment versus Neoadjuvant Systemic Therapy Followed by Local Treatment (COLLISION RELAPSE): Study Protocol of a Phase III Prospective Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2024 Feb;47(2):253-262. doi: 10.1007/s00270-023-03602-y. Epub 2023 Nov 9.

    PubMed 37943351

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) and Repeat local treatment in people with Colorectal Cancer and Liver Metastases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact M Dijkstra (+31(0)204444444, interventieradiologie@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) per patient (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05861505, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

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