Vitamin D3
Conditions
Keywords
mCRC, oxaliplatin plus fluoropyrimidine
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.
Interventions
DRUGvitamin D3
vitamin D3 400IU\*5pills po. qd continue to disease progression
DRUGPlacebo
placebo 5 pills po. qd continue to disease progression
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blined
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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: 1. Hemoglobin ≥9.0g/dL; 2. Neutrophils ≥1500/mm3; 3. Platelet ≥100,000/mm3; 4. Total Bilirubin ≤1.5\*ULN 5. 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) 6. 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 criteria
* Concurrent diseases: 1. Prior malignancy active cancer except for locally curable cancer that have been cured over 5years,or carcinoma in situ. 2. Known brain metastasis 3. Any serious or uncontrolled medical disorder or active infection. 4. Known history of positive test for HIV or AIDS; 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| OS(overall survival) | 5 years | OS is defined the time between the date of randomization and the date of death. |
| DCR | up to 1 year | disease control rate |
| ORR | up to 1 year | overall response rate |
| Incidence of Treatment-Emergent Adverse Events | through study completion, an average of 1 year | all the adverse events |
Contacts
Primary ContactTing Deng
Outcome results
None listed