XELOX/mFOLFOX Plus Vitamin D3 vs. XELOX/mFOLFOX as Firstline Chemotherapy in mCRC
- Registration Number
- NCT03389659
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 750
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Signed written informed consent.
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males and females, ≥18 years of age
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All subjects must have inoperable, advanced or metastatic colorectal cancer and have confirmed histologically adenocarcinoma.
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Subject must be previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease.
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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.
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ECOG performance status score of 0 or 1.
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Subjects must have at least one measurable lesion or evaluable disease by CT of MRI per RECIST1.1 criteria.
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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
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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.
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Life expectancy ≥3 months.
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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;
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Within 4 weeks before randomization had operation, enlarged area radiotherapy(local radiotherapy within 2weeks) and other study drugs.
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Subjects with ≥ Grade 2 peripheral neuropathy.
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Pregnancy or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Placebo 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) Vitamin D3 group vitamin D3 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)
- Primary Outcome Measures
Name Time Method PFS(progression-free survival) 5 years PFS is defined the time from the date of randomization to the date of disease progression or death due to any cause.
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events through study completion, an average of 1 year all the adverse events
DCR up to 1 year disease control rate
OS(overall survival) 5 years OS is defined the time between the date of randomization and the date of death.
ORR up to 1 year overall response rate