Radioembolization in Elderly/ Fragile Patients With mCRC

Trial details

Who runs it

UMC Utrecht

Trial code

NCT05092880

Record updated

14 May 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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); 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; 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; Mental disorders that may compromise patient compliance; Known severe allergy for intravenous contrast fluids; Non-correctable INR >2.0; 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; Pregnancy or breastfeeding; Body weight over 150 kg (because of maximum table load); Participation to another investigational study.

ClinicalTrials.gov NCT05092880