Radioembolization in Elderly/ Fragile Patients With mCRC (NCT05092880) | Clinical Trial Compass
RecruitingPhase 2
Radioembolization in Elderly/ Fragile Patients With mCRC
Netherlands220 participantsStarted 2022-06-01
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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).
✕. 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.