Minimally invasive treatment for elderly patients with liver metastases from colorectal cancer

Radioembolization in Elderly/Fragile Patients With Unresectable Livermetastases of Colorectal Cancer, CAIRO7 Study of the DCCG

This study is testing a new, less invasive treatment using radioactive particles for older patients with liver cancer from colorectal cancer to see if it works better and is easier on them than standard treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UMC Utrecht (other)
• Drugs / interventions: chemotherapy, bevacizumab
• Locations: 1 site (Utrecht)
• Trial ID: NCT05092880 on ClinicalTrials.gov

What this trial studies

This study investigates the use of radioembolization (RE), a minimally invasive procedure that delivers radioactive microspheres directly into the hepatic artery, as a treatment for elderly or frail patients with metastatic colorectal cancer confined to the liver. The aim is to compare the efficacy and tolerability of RE against standard systemic treatments, which often lead to significant toxicity. By focusing on this patient population, the study seeks to provide a safer and more effective alternative to traditional therapies, potentially improving quality of life and progression-free survival. The study will enroll patients who have not previously received systemic treatment for their metastatic disease.

Who should consider this trial

Good fit: Ideal candidates are elderly or frail patients aged 18 years or older with metastatic colorectal cancer confined to the liver who have not received prior systemic treatment.

Not a fit: Patients who have previously undergone systemic treatment for metastatic disease or those with extensive liver metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a safer and more effective option for elderly patients suffering from metastatic colorectal cancer, improving their quality of life.

How similar studies have performed: Other studies have shown promising results with radioembolization in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients must have given written informed consent.
2. Female or male patients aged ≥18 years.
3. Metastatic colorectal cancer, with metastases confined to the liver, previously not systemically treated.
4. Previous local treatment of liver metastases by resection of a maximum of two liver segments and/or local ablation is allowed.
5. Elderly/frail patients, according to the local investigator not eligible for local treatments or intensive systemic regimens with combination chemotherapy.
6. ECOG Performance status 0-2 (Table 1).
7. Eligible for systemic treatment with capecitabine + anti-VEGF antibody.
8. 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.

Exclusion Criteria:

1. Previous systemic treatment for metastatic disease.
2. Previous adjuvant treatment completed within 6 months prior to randomization.
3. Symptoms of primary tumour, if in situ, that require intervention; prior treatment with (chemo)radiotherapy and/or resection of primary tumor is allowed.
4. Resection of more than 2 liver segments, 2-stage procedures and/or radiotherapy of liver metastases.
5. Eligible for more intensive systemic regimens (i.e. doublet or triplet chemotherapy).
6. Eligible for local treatment of liver metastases (e.g. surgical resection, ablation).
7. 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.
8. Non-correctable INR \>2.0.
9. 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.
10. Pregnancy or breastfeeding.
11. Mental disorders that may compromise patient compliance.
12. 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.
13. Body weight over 150 kg (because of maximum table load).
14. Known severe allergy for intravenous contrast fluids.
15. Participation to another investigational study.

Where this trial is running

Utrecht

• UMC Utrecht — Utrecht, Netherlands (RECRUITING)

Conditions: Colorectal Cancer Metastatic