NCT05092880终止2 期

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

UMC Utrecht2 个研究点分布在 1 个国家目标入组 18 人开始时间: 2022年6月1日最近更新: 2026年5月14日

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.
•Non-correctable INR >2.
•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.

研究组 & 干预措施

Standard of care first-line systemic therapy

Active Comparator

capecitabine plus anti-VEGF antibody

干预措施: Standard of care first-line systemic therapy (Drug)