Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 10
- 主要终点
- Progression Free Survival
研究概览
简要总结
In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and strategy stratification are lacking. In this setting, a simple biological scoring system have recently been proposed, including LDH and CD138 binary status seric values, identifying one third of patients with worst prognostic.
Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E mutation, concerning 5-8% of first line mCRC.
For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard chemotherapy arm, in order to better discriminate treatment strategies, at metastatic diagnosis.
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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Performance status ECOG-WHO 0 or 1
- •Histologically proved metastatic colorectal adenocarcinoma, with non-resectable metastases
- •Adequate hematological, hepatic, and renal functions
- •Signed written informed consent
排除标准
- •Previous treatment (chemotherapy, targeted therapy, surgery) for metastatic disease
- •History of autoimmune disease
- •Acute infectious disease
- •Known hypersensitivity grade 3-4 or contraindication to any of the study drugs
- •Patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.
- •Bevacizumab contraindication
- •Brain metastases
- •Other malignancy within the last 2 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- •Pregnancy, breast-feeding or absence of adequate contraception for fertile patients
- •Patient under guardianship, curator or under the protection of justice.
研究组 & 干预措施
Arm A : FOLFOXIRI - bevacizumab
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
干预措施: FOLFOXIRI (Drug)
Arm A : FOLFOXIRI - bevacizumab
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
干预措施: Bevacizumab (Drug)
Arm A : FOLFOXIRI - bevacizumab
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
干预措施: LV5FU2 (Drug)
Arm A : FOLFOXIRI - bevacizumab
FOLFOXIRI + bevacizumab, 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 or bevacizumab-capecitabine) until disease progression or limiting toxicities
干预措施: Capecitabine (Drug)
Arm B: FOLFOX or FOLFIRI - bevacizumab
FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
干预措施: FOLFOX (Drug)
Arm B: FOLFOX or FOLFIRI - bevacizumab
FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
干预措施: FOLFIRI (Drug)
Arm B: FOLFOX or FOLFIRI - bevacizumab
FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
干预措施: Bevacizumab (Drug)
Arm B: FOLFOX or FOLFIRI - bevacizumab
FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
干预措施: LV5FU2 (Drug)
Arm B: FOLFOX or FOLFIRI - bevacizumab
FOLFOX or FOLFIRI + bevacizumab 12 cures following by maintenance chemotherapy (bevacizumab + LV5FU2 ou bevacizumab capecitabine) until disease progression or limiting toxicities
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: up to 4 years (3 years of inclusion and 12 months of follow up after the last patient included)
Delay from the date of randomization to the disease progression (RECIST) or death from any cause whichever occurs first
次要结局
未报告次要终点