NL-OMON56361招募中2 期
Radioembolization with 166Ho-microspheres in elderly and/or fragile patients with previously untreated unresectable liver-only metastases of colorectal cancer, CAIRO7 study endorsed by the Dutch Colorectal Cancer Group (DCCG) - CAIRO7
niversitair Medisch Centrum Utrecht0 个研究点目标入组 220 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •4.2 Inclusion criteria
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following 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
- •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), Albumin >= 30 g/L,
- •/ALAT <= 5x (ULN), and renal (GFR >= 40 ml/min) functions.
排除标准
- •4.3 Exclusion criteria
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Previous systemic treatment for metastatic disease.
- •2. Previous adjuvant treatment completed within 6 months prior to randomization.
- •3. Symptoms of primary tumor, if in situ, that require intervention; prior
- •treatment with (chemo)radiotherapy and/or resection of primary tumor is
- •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,
- •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 and/or chronic liver disease preventing the safe administration
- •of radioembolization
- •10. 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
- •11. Pregnancy or breastfeeding.
- •12. Mental disorders that may compromise patient compliance.
- •13. Active second malignancy within the previous 5 years, with the exception of
- •adequately treated basal cell carcinoma of skin and in situ carcinoma of
- •14. Body weight over 150 kg (because of maximum table load).
- •15. Known severe allergy for intravenous contrast fluids.
- •16. Actual or planned participation to another investigational study which may
- •compromise any endpoint of the study. This also applies to any intervention
- •that may influence quality of life.
研究者
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