2024-516844-25-01招募中2 期
REVOLUTION - Randomized phasE 2 study of Valproic acid in combination with bevacizumab and Oxaliplatin/fLUoropyrimidine regimens in patients with ras-mutated metastaTIc cOlorectal caNcer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- PFS progression-free survival
研究概览
简要总结
To test whether the combination of valproic acid with bevacizumab and oxaliplatin/fluoropyrimidine regimens (mFOLFOX6/mOXXEL) can prolong progression free survival (PFS) as compared with bevacizumab and oxaliplatin/fluoropyrimidine regimens alone as first-line treatment in patients with metastatic colorectal cancer with mutation of RAS.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age = 18 • Histologically confirmed diagnosis of colorectal adenocarcinoma • Stage IV of disease (according to TNM 8th edition) • RAS mutations • Clinical or radiologic evidence of disease (at least one target according to RECIST 1.1) • ECOG performance status 0 to 1 • Life expectancy > 3 months • Use of an acceptable mean of contraception for men and women of childbearing potential • Adequate recovery from previous surgery. At least 28 days should elapse from a surgical procedure or from performing a biopsy for the enrolment into the study • Written informed consent
排除标准
- •Tumors without RAS mutations • Prior chemotherapy or any other medical treatment for advanced mCRC (previous adjuvant chemotherapy is allowed if ended > 6 months before relapse or > 24 months if the adjuvant treatment included oxaliplatin) • Radiotherapy to any site for any reason within 28 days prior to randomization (palliative radiotherapy to bone lesions is allowed if = 14 days before randomization) • Any other invasive malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA) • Patient who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid • Known dihydropyrimidine dehydrogenase (DPD) deficiency • Pregnancy or nursing • Concomitant pathologies or laboratory alterations or concomitant medications use that prevent or contraindicate the use of study drugs • Brain metastases
结局指标
主要结局
PFS progression-free survival
PFS progression-free survival
次要结局
- centrally reviewed PFS (CR-PFS)
研究者
Maria Carmela Piccirillo
Scientific
IRCCS Istituto Nazionale Tumori Fondazione Pascale
研究点 (8)
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