NCT04188145进行中（未招募）3 期
A Randomized Phase III Study Comparing Maintenance Treatment With Fluoropyrimidine + Bevacizumab Versus Fluoropyrimidine After Induction Chemotherapy for a Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The Time-to-Treatment Failure (TTF)
研究概览
简要总结
The aim of BEVAMAINT is to improve benefic effect of maintenance therapy after a first line of induction chemotherapy for patients with colorectal cancer
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
- •Histologically confirmed metastatic colorectal adenocarcinoma before induction treatment
- •Measurable or non-measurable lesion before the induction treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- •Metastatic, unresectable disease according local practice after induction treatment
- •ECOG performance status ≤ 2
- •Disease control (complete response, partial response or stable disease) after 4-6 months of frontline induction chemotherapy with doublet (fluoropyrimidine + irinotecan or oxaliplatin) or triplet (fluoropyrimidine + irinotecan + oxaliplatin) +/- (cetuximab, panitumumab, bevacizumab) or IAH chemotherapy
- •Life expectancy > 3 months
- •Age ≥ 18 years
- •Patient is at least 4 weeks from any major surgery
- •Total bilirubin < 25 µmol/L, ASAT < 3 x ULN, ALAT < 3 x ULN (ASAT , ALAT < 5 x ULN in case of hepatic metastasis) , PT >60% , PAL<2.5 x ULN ( < 5 x ULN in case of hepatic metastasis) - Neutrophils > 1500/mm3, platelets > 100 000/mm3, haemoglobin ≥ 9 g/dL
- •Creatinin clearance > 30 ml/min (MDRD) - if creatinin clearance comprised between 30 and 50 ml/min, see smPCs for dose adjustments
- •Proteinuria ≤ 2+ (dipstick urinalysis) (if more than 2+, so proteinuria at or ≤1g/24hour must be ≤1g)
- •Patient is able to understand, sign, and date the written informed consent
- •Evidence of post-menopausal status or negative urinary or serum pregnancy test for premenopausal female patients
- •Male and female patients of childbearing potential agree to use a highly effective contraceptive measure
- •Patient affiliated to a social security system
排除标准
- •Myocardial infarction, severe coronaropathy or severe cardiac dysfunction less than 6 months prior randomization
- •Follow-up impossible
- •Patients with all metastases resected (R0/R1) after induction chemotherapy
- •Patient with a hand-foot syndrome > 1 before maintenance treatment
- •Known brain or leptomeningeal metastases
- •Other concomitant or previous malignancy, except: adequately treated in situ carcinoma in complete remission for > 5 years
- •Uncontrolled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure >90 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy
- •Pregnancy or breast feeding
- •Treatment with sorivudine or analogs (brivudine)
- •Treatment with phenytoin or analogs
- •Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)
- •Peptic ulcer not healed after treatment
- •Any contraindication to bevacizumab or fluoropyrimidine treatments according to the updated SmPC
- •Intestinal perforation or intestinal fistula
- •Previous or active gastrointestinal bleeding
- •Thromboembolic event and/or history of thromboembolic event
- •Severe hepatic insufficiency
研究组 & 干预措施
Fluoropyrimidine + Bevacizumab
Active Comparator
干预措施: Bevacizumab (Drug)
Fluoropyrimidine
Active Comparator
干预措施: Fluoropyrimidine (Drug)
Fluoropyrimidine + Bevacizumab
Active Comparator
干预措施: Fluoropyrimidine (Drug)
结局指标
主要结局
The Time-to-Treatment Failure (TTF)
时间窗: 8 months
Will be calculated from date of randomization (after the end of induction chemotherapy) to first radiological progression (according to RECIST 1.1) or death or start of a new chemotherapy (induction regimen or second line) or end of maintenance treatment without further chemotherapy, even if there is no radiological progression. Patients alive with no radiological progression and under maintenance treatment will be censored at the date of last news.
次要结局
- Overall Survival (OS)(3 years)
- Quality of Life (QoL)(3 years)
- Progression-free survival (PFS1)(16 months)
- Progression-free survival (PFS2)(16 months)
- Safety(3 years)
研究者
研究点 (2)
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