A Randomized, Multicenter, Double-blinded, Phase III Study of Vitamin D3 in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine as First-line Chemotherapy in Previously Untreated Advanced or Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 750
- 主要终点
- PFS(progression-free survival)
研究概览
简要总结
The study is a randomized,multicenter, double-blinded,phase III study. To explore the affection of vitamin D3 in combination with oxaliplatin plus fluoropyrimidine versus oxaliplatin plus fluoropyrimidine as first-line chemotherapy in previously untreated advanced or metastatic 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
- Double (Participant, Investigator)
盲法说明
double-blined
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
- •Signed written informed consent.
- •males and females, ≥18 years of age
- •All subjects must have inoperable, advanced or metastatic colorectal cancer and have confirmed histologically adenocarcinoma.
- •Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.
- •Prior adjuvant or neoadjuvant chemotherapy and/or radiotherapy are permitted as long as the last administration of the last regimen occurred at least 12 months prior to randomization.
- •ECOG performance status score of 0 or
- •Subjects must have at least one measurable lesion or evaluable disease by CT of MRI per RECIST1.1 criteria.
- •Screening laboratory values must meet the following criteria in 7days before the first day of cycle 1:
- •Hemoglobin ≥9.0g/dL;
- •Neutrophils ≥1500/mm3;
- •Platelet ≥100,000/mm3;
- •Total Bilirubin ≤1.5*ULN
- •AST ≤2.5*ULN (or ≤5.0*ULN if liver metastases are present), and ALT ≤2.5*ULN (or ≤5.0*ULN if liver metastases are present)
- •Serum creatinine ≤1.5*ULN or calculated creatinine clearance >50mL/min
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before randomization. All subjects of childbearing potential must agree to follow instructions for method of contraception for the duration of study treatment and 6 months after the last dose of study treatment.
- •Life expectancy ≥3 months.
排除标准
- •Concurrent diseases:
- •Prior malignancy active cancer except for locally curable cancer that have been cured over 5years,or carcinoma in situ.
- •Known brain metastasis
- •Any serious or uncontrolled medical disorder or active infection.
- •Known history of positive test for HIV or AIDS;
- •Hepatitis B virus or hepatitis C virus is active;
- •Within 4 weeks before randomization had operation, enlarged area radiotherapy(local radiotherapy within 2weeks) and other study drugs.
- •Subjects with ≥ Grade 2 peripheral neuropathy.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Vitamin D3 group
vitamin D3 2000IU (400IU*5pills） po. qd continue to disease progression plus XELOX (oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 bid po. d1-14; q3w) or mFOLFOX (oxaliplatin 85mg/m2，d1; leucovorin 400mg/m2，d1；5-fluorouracil 400mg/m2，d1; 5-fluorouracil 2400mg/m2 continue 46h, q2w)
干预措施: vitamin D3 (Drug)
control group
placebo 5 pills po. qd continue to disease progression plus XELOX (oxaliplatin 130mg/m2 d1; capecitabine 1000mg/m2 bid po. d1-14; q3w) or mFOLFOX (oxaliplatin 85mg/m2，d1; leucovorin 400mg/m2，d1；5-fluorouracil 400mg/m2，d1; 5-fluorouracil 2400mg/m2 continue 46h, q2w)
干预措施: Placebo (Drug)
结局指标
主要结局
PFS(progression-free survival)
时间窗: 5 years
PFS is defined the time from the date of randomization to the date of disease progression or death due to any cause.
次要结局
- Incidence of Treatment-Emergent Adverse Events(through study completion, an average of 1 year)
- DCR(up to 1 year)
- OS(overall survival)(5 years)
- ORR(up to 1 year)