Status:
UNKNOWN
XELOX/mFOLFOX Plus Vitamin D3 vs. XELOX/mFOLFOX as Firstline Chemotherapy in mCRC
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Vitamin D3
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 fluoropyrimi...
Eligibility Criteria
Inclusion
- 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 1.
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT03389659
Start Date
February 1 2018
End Date
June 1 2022
Last Update
January 3 2018
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