NL-OMON52926招募中3 期
Adjuvant hepatic arterial infusion pump chemotherapy after resection of colorectal liver metastases in patients with a low clinical risk score - a randomized controlled trial - Adjuvant hepatic arterial infusion pump chemotherapy after resection of CLM
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 230
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
- •Age >= 18 years. • ECOG performance status 0 or 1 • Clinical Risk Score (CRS)
- •of 0-2 • Histologically confirmed colorectal cancer (CRC) • Radiologically
- •confirmed CLM amenable for resection or open ablation • Positioning of a
- •catheter for HAIP chemotherapy is technically feasible based on a CT with early
- •arterial phase with 1mm cuts • Adequate bone marrow, liver and renal function
- •conducted within 15 days prior to inclusion.
排除标准
- •Presence of extrahepatic disease (including positive portal lymph nodes) at
- •the time of liver resection or any time since CRC diagnosis. Patients with
- •small (<= 1 cm) extrahepatic lesions that are not clearly suspicious of
- •metastases are eligible. • Second primary malignancy except in situ carcinoma
- •of the cervix, adequately treated non-melanoma skin cancer, or other malignancy
- •treated at least 5 years previously without evidence of recurrence. • Prior
- •hepatic radiation, resection, or ablation. • CLM requiring two-staged
- •resections. • Liver-first resections. • Postoperative radiation of
- •non-surgically treated (resection or open ablation) CLM • (Partial) portal vein
- •thrombosis.
- •Known DPD-deficiency (heterozygous or homozygous) • Pregnant women or
- •lactating women.
- •History of psychiatric disability judged by the investigator to be clinically
- •significant, precluding informed consent or interfering with compliance for
- •HAIP chemotherapy. • Serious concomitant systemic disorders that would
- •compromise the safety of the patient or his/her ability to complete the study,
- •at the discretion of the investigator. • Organ allografts requiring
- •immunosuppressive therapy.
- •Serious, non-healing wound, ulcer, or bone fracture. • Chronic treatment with
- •corticosteroids (dose of >= 10 mg/day methylprednisolone equivalent excluding
- •inhaled steroids). • Serious infections (uncontrolled or requiring
- •treatment). • Participation in another interventional study for CLM with
- •survival as outcome. • Participation in another prospective study with an
- •interventional medical product. • Any psychological, familial, sociological or
- •geographical condition potentially hampering compliance with the study protocol
- •and follow-up schedule; those conditions should be discussed with the patient
- •before registration in the trial.
研究者
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