NCT02788006已完成2 期
Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .
Federation Francophone de Cancerologie Digestive16 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 16
- 主要终点
- Percentage of Patients With a Tumoral Control Rate at 2 Months
研究概览
简要总结
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic colorectal cancer with histological proof
- •Measurable disease according RECIST 1.1
- •Age ≥ 70 years
- •Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min
- •Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities
- •Geriatric Questionnaires answered
- •Life-expectancy ≥ 3 months
- •Informed Consent Signed
排除标准
- •Not able to swallow tablets (crushed tablets are not allowed)
- •Previous treatment with regorafenib or other multikinase treatment
- •Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated
- •Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion
- •Toxicity > grade 1 not resolved with previous treatment
- •Major surgery in the 28 days before the inclusion
- •Non cicatrized injury, ulcer or bone fracture
- •Congestive Cardiac insufficiency classe >2 (NYHA)
- •Unstable angor in the last 3 months
- •Myocardial Infraction in the 6 months before inclusion
- •HTA not controlled
- •Pheochromocytome
- •Arterial or venous thromboembolism in the past 6 months
- •Infection of grade > 2
- •VIH infection
- •B or C hepatitis necessiting a specific treatment
- •Cirrhosis
- •Suspicion of brain metastasis or brain metastasis
- •Haemorraghe ofgrade >3 in the last weeks
- •Symptomatic Pulmonary fibrosis
- •Proteinuria > grade 3
- •Malabsorption
- •Allergy know to the treatment or to one similar treatment or to one treatment component
- •Systemic anti-cancer drug during the study or the the last 4 weeks
- •Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor
- •Social, psychological or medical condition which can interfere with the study participation
研究组 & 干预措施
Regorafenib 160 mg
Experimental
干预措施: Regorafenib 160 mg (Drug)
结局指标
主要结局
Percentage of Patients With a Tumoral Control Rate at 2 Months
时间窗: 2 months after the start of treatment
Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression.
次要结局
- Overall Survival(Up to approximatively 1 year after the end of the treatment)
研究者
研究点 (16)
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