Colorectal Cancer MetastaticPhase 2CAIRO7NCT05092880
Radioembolization in Elderly/ Fragile Patients With mCRC
A Phase 2 study testing radioembolization in people with Colorectal Cancer Metastatic, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter. Since tumors are preferentially supplied by the hepatic artery, most microspheres get trapped in the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- radioembolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2022to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients must have given written informed consent.
- Female or male patients aged ≥18 years.
- Metastatic colorectal cancer, with metastases confined to the liver, previously not systemically treated.
- Previous local treatment of liver metastases by resection of a maximum of two liver segments and/or local ablation is allowed.
- Elderly/frail patients, according to the local investigator not eligible for local treatments or intensive systemic regimens with combination chemotherapy.
- ECOG Performance status 0-2 (Table 1).
- Eligible for systemic treatment with capecitabine + anti-VEGF antibody.
- Adequate bone marrow (Hb ≥ 6 mmol/L, WBC ≥ 3x109/L, platelets ≥ 100x109/L), liver (serum bilirubin ≤ 1x upper limit of normal (ULN), ASAT/ALAT ≤ 5x ULN), and renal (GFR ≥ 40 ml/min) functions.
Who cannot join
- Previous systemic treatment for metastatic disease.
- Previous adjuvant treatment completed within 6 months prior to randomization.
- Symptoms of primary tumour, if in situ, that require intervention; prior treatment with (chemo)radiotherapy and/or resection of primary tumor is allowed.
- Resection of more than 2 liver segments, 2-stage procedures and/or radiotherapy of liver metastases.
- Eligible for more intensive systemic regimens (i.e. doublet or triplet chemotherapy).
- Eligible for local treatment of liver metastases (e.g. surgical resection, ablation).
Show all 15Show fewer
- Presence of extrahepatic metastases; the presence of small (≤ 1 cm) lesions outside the liver on CT scan that are not clearly suspicious for metastases and/or the presence of enlarged hilar lymph nodes in the liver up to a maximal diameter of 2 cm is allowed.
- Non-correctable INR >2.0.
- Any serious comorbidity preventing the safe administration of anti-VEGF antibody treatment. This includes uncontrolled hypertension or treatment with ≥3 antihypertensive drugs, arterial (cerebro)vascular event within the past 12 months, history of bleeding, history of GI perforation, or presence of fistulae.
- Pregnancy or breastfeeding.
- Mental disorders that may compromise patient compliance.
- Active second malignancy within the previous 5 years, with the exception of adequately treated basal cell carcinoma of skin and in situ carcinoma of cervix.
- Body weight over 150 kg (because of maximum table load).
- Known severe allergy for intravenous contrast fluids.
- Participation to another investigational study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radioembolization in Elderly/Fragile Patients With Unresectable Livermetastases of Colorectal Cancer, CAIRO7 Study of the DCCG
Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter. Since tumors are preferentially supplied by the hepatic artery, most microspheres get trapped in the tumor. RE has been shown a feasible and safe procedure for the treatment of unresectable CRC liver metastases. These data compare favourably with the toxicity data of capecitabine plus bevacizumab, but this should be validated in a prospective study.
The proposed study investigates the efficacy of RE as an alternative, better tolerated and more cost-effective treatment option in elderly or frail patients compared to chronic systemic treatment with comparable progression-free survival.
Read the detailed description
Rationale In The Netherlands, ±14.000 people/year are diagnosed with colorectal cancer (CRC), and 50% of patients already have/will develop distant metastases, most commonly to the liver. Standard treatment is palliative systemic treatment, which prolongs overall survival (OS). In only a small subset of patients with liver-only metastases, local treatment (i.e. surgery) of metastases is possible with curative intent, either initially or after downsizing by intensive systemic treatment. The average age at CRC diagnosis is 69 yrs, and 30% of CRC patients are ≥75 yrs. Thus, many patients are too old and/or fragile to allow intensive systemic regimens or major surgery. In frail/elderly patients the standard treatment is capecitabine plus an antibody against the vascular endothelial growth factor (VEGF, i.e. bevacizumab or biosimilar), given until disease progression or unacceptable toxicity, resulting in a median progression free survival (PFS) of 8.5-9.2 months. Capecitabine-induced hand-foot syndrome and diarrhoea are the most commonly occurring toxicities. Prolonged exposure to CTCAE grade 2 toxicity in frail or elderly patients may already significantly impact quality of life and daily functioning. Therefore, treatments with less toxicity would be of great value for these patients.
Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter. Since tumors are preferentially supplied by the hepatic artery, most microspheres get trapped in the tumor. RE has been shown a feasible and safe procedure for the treatment of unresectable CRC liver metastases. These data compare favourably with the toxicity data of capecitabine plus bevacizumab, but this should be validated in a prospective study.
The proposed study investigates the efficacy of RE as an alternative, better tolerated and more cost-effective treatment option in elderly or frail patients compared to chronic systemic treatment with comparable progression-free survival.
Objectives:
Primary objective:
The objective of this randomized phase 2 study is to demonstrate efficacy of a single RE in terms of PFS in CRC patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus anti-VEGF antibody (bevacizumab or biosimilar).
Secondary objectives:
- To evaluate safety/toxicity.
- To evaluate cost-effectiveness.
- To evaluate quality of life (QoL).
- To evaluate overall survival.
Study design:
Multi-center, interventional, treatment, randomized phase 2, open label, comparative study. The study will be conducted within the network of the Dutch Colorectal Cancer Group (DCCG). Patients will be randomized 1:1 between RE and systemic treatment with capecitabine + anti-VEGF antibody.
Study population:
220 elderly and/or fragile patients with liver-limited, unresectable metastatic colorectal cancer, previously not systemically treated, who are candidates for systemic treatment with capecitabine plus an anti-VEGF antibody, will be enrolled in this study. Given the lack of validated selection criteria for elderly and/or frail this judgement will be left to the discretion of the local investigator.
Intervention:
Individualized holmium-166 radioembolization (166Ho-RE) will be performed via a catheter during angiography. Dosimetry-based treatment planning will be individualized using Q-Suite™ software. The comparator, standard systemic treatment, will be given by the local investigator and will consist of capecitabine orally 1000 mg/m2 bid day 1-14 + anti-VEGF antibody i.v. 7.5 mg/kg day 1 at 3-weekly cycles, continued until disease progression or unacceptable toxicity.
Main study parameters/endpoints:
Primary endpoint:
Progression-free survival.
Secondary endpoints:
- Safety/toxicity.
- Cost-effectiveness.
- QoL.
- Overall survival.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- radioembolization, Standard of care first-line systemic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioembolizationDevice
holmium-166 microspheres
Standard of care first-line systemic therapyDrug
Capecitabine plus anti-VEGF antibody
| Study group | Role | What they receive |
|---|---|---|
| Standard of care first-line systemic therapy | Active comparator | capecitabine plus anti-VEGF antibody Receives: Drug: Standard of care first-line systemic therapy |
| Radioembolization | Experimental | radioembolization of liver with holmium-166 microspheres Receives: Device: radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 4 years
Secondary outcomes (7)
Adverse event frequency and grade according to CTCAE version 5.0
Measured: 3.5 years
Quality of life (EORTC quality of life questionnaire number C30)
For all questionnaires the official manuals will be used to calculate the subscales.
Measured: 3.5 years
Quality of life (EORTC quality of life questionnaire number CR29)
For all questionnaires the official manuals will be used to calculate the subscales.
Measured: 3.5 years
Quality of life (Multidimensional Fatigue Inventory: MFI-20)
For all questionnaires the official manuals will be used to calculate the subscales.
Measured: 3.5 years
Overall survival
Measured: 5 years
Cost-effectiveness: Medical Consumption Questionnaire (MCQ)
For all questionnaires the official manuals will be used to calculate the subscales.
Measured: 4 years
Cost-effectiveness: Productivity Cost Questionnaire (PCQ)
For all questionnaires the official manuals will be used to calculate the subscales.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Jun 2022
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Why it stopped: The medical deviced studied was taken off market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized phase 2
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Colorectal Cancer Group
- Responsible party
- Principal investigator, Marnix G.E.H. Lam, MD, PhD, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092880
- Sponsor's protocol ID
- CAIRO7
- Acronym
- CAIRO7
- Status last verified
- May 2026
- First submitted
- 30 Jul 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioembolization in Elderly/Fragile Patients With Unresectable Livermetastases of Colorectal Cancer, CAIRO7 Study of the DCCG
- ClinicalTrials.gov ID
- NCT05092880
- Acronym / sponsor ID
- CAIRO7 / CAIRO7
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The medical deviced studied was taken off market
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Dutch Colorectal Cancer Group
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter. Since tumors are preferentially supplied by the hepatic artery, most microspheres get trapped in the tumor. RE has been shown a feasible and safe procedure for the treatment of unresectable CRC liver metastases. These data compare favourably with the toxicity data of capecitabine plus bevacizumab, but this should be validated in a prospective study.
The proposed study investigates the efficacy of RE as an alternative, better tolerated and more cost-effective treatment option in elderly or frail patients compared to chronic systemic treatment with comparable progression-free survival.
Detailed description
Rationale In The Netherlands, ±14.000 people/year are diagnosed with colorectal cancer (CRC), and 50% of patients already have/will develop distant metastases, most commonly to the liver. Standard treatment is palliative systemic treatment, which prolongs overall survival (OS). In only a small subset of patients with liver-only metastases, local treatment (i.e. surgery) of metastases is possible with curative intent, either initially or after downsizing by intensive systemic treatment. The average age at CRC diagnosis is 69 yrs, and 30% of CRC patients are ≥75 yrs. Thus, many patients are too old and/or fragile to allow intensive systemic regimens or major surgery. In frail/elderly patients the standard treatment is capecitabine plus an antibody against the vascular endothelial growth factor (VEGF, i.e. bevacizumab or biosimilar), given until disease progression or unacceptable toxicity, resulting in a median progression free survival (PFS) of 8.5-9.2 months. Capecitabine-induced hand-foot syndrome and diarrhoea are the most commonly occurring toxicities. Prolonged exposure to CTCAE grade 2 toxicity in frail or elderly patients may already significantly impact quality of life and daily functioning. Therefore, treatments with less toxicity would be of great value for these patients.
Radioembolization (RE) is a minimally invasive treatment with administration of radioactive microspheres into the hepatic artery via a microcatheter. Since tumors are preferentially supplied by the hepatic artery, most microspheres get trapped in the tumor. RE has been shown a feasible and safe procedure for the treatment of unresectable CRC liver metastases. These data compare favourably with the toxicity data of capecitabine plus bevacizumab, but this should be validated in a prospective study.
The proposed study investigates the efficacy of RE as an alternative, better tolerated and more cost-effective treatment option in elderly or frail patients compared to chronic systemic treatment with comparable progression-free survival.
Objectives:
Primary objective:
The objective of this randomized phase 2 study is to demonstrate efficacy of a single RE in terms of PFS in CRC patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus anti-VEGF antibody (bevacizumab or biosimilar).
Secondary objectives:
- To evaluate safety/toxicity.
- To evaluate cost-effectiveness.
- To evaluate quality of life (QoL).
- To evaluate overall survival.
Study design:
Multi-center, interventional, treatment, randomized phase 2, open label, comparative study. The study will be conducted within the network of the Dutch Colorectal Cancer Group (DCCG). Patients will be randomized 1:1 between RE and systemic treatment with capecitabine + anti-VEGF antibody.
Study population:
220 elderly and/or fragile patients with liver-limited, unresectable metastatic colorectal cancer, previously not systemically treated, who are candidates for systemic treatment with capecitabine plus an anti-VEGF antibody, will be enrolled in this study. Given the lack of validated selection criteria for elderly and/or frail this judgement will be left to the discretion of the local investigator.
Intervention:
Individualized holmium-166 radioembolization (166Ho-RE) will be performed via a catheter during angiography. Dosimetry-based treatment planning will be individualized using Q-Suite™ software. The comparator, standard systemic treatment, will be given by the local investigator and will consist of capecitabine orally 1000 mg/m2 bid day 1-14 + anti-VEGF antibody i.v. 7.5 mg/kg day 1 at 3-weekly cycles, continued until disease progression or unacceptable toxicity.
Main study parameters/endpoints:
Primary endpoint:
Progression-free survival.
Secondary endpoints:
- Safety/toxicity.
- Cost-effectiveness.
- QoL.
- Overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized phase 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care first-line systemic therapy | Active comparator | Drug: Standard of care first-line systemic therapycapecitabine plus anti-VEGF antibody |
| Radioembolization | Experimental | Device: radioembolizationradioembolization of liver with holmium-166 microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have given written informed consent.
- Female or male patients aged ≥18 years.
- Metastatic colorectal cancer, with metastases confined to the liver, previously not systemically treated.
- Previous local treatment of liver metastases by resection of a maximum of two liver segments and/or local ablation is allowed.
- Elderly/frail patients, according to the local investigator not eligible for local treatments or intensive systemic regimens with combination chemotherapy.
Key exclusion criteria (15 listed)
- Previous systemic treatment for metastatic disease.
- Previous adjuvant treatment completed within 6 months prior to randomization.
- Symptoms of primary tumour, if in situ, that require intervention; prior treatment with (chemo)radiotherapy and/or resection of primary tumor is allowed.
- Resection of more than 2 liver segments, 2-stage procedures and/or radiotherapy of liver metastases.
- Eligible for more intensive systemic regimens (i.e. doublet or triplet chemotherapy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radioembolizationholmium-166 microspheres | Device | Radioembolization |
| Standard of care first-line systemic therapyCapecitabine plus anti-VEGF antibody | Drug | Standard of care first-line systemic therapy |
Primary outcome
progression-free survival
Time frame: 4 years
7 secondary outcomes
Adverse event frequency and grade according to CTCAE version 5.0
Time frame: 3.5 years
Quality of life (EORTC quality of life questionnaire number C30)
Time frame: 3.5 years
Quality of life (EORTC quality of life questionnaire number CR29)
Time frame: 3.5 years
Quality of life (Multidimensional Fatigue Inventory: MFI-20)
Time frame: 3.5 years
Overall survival
Time frame: 5 years
Cost-effectiveness: Medical Consumption Questionnaire (MCQ)
Time frame: 4 years
Cost-effectiveness: Productivity Cost Questionnaire (PCQ)
Time frame: 4 years
Results and safety
The study was stopped early (reason given: The medical deviced studied was taken off market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radioembolization in people with Colorectal Cancer Metastatic, run by UMC Utrecht 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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 May 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The medical deviced studied was taken off market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2026.