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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 group | Experimental | 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) |
|
| control group | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 | Drug | vitamin D3 400IU*5pills po. qd continue to disease progression |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PFS(progression-free survival) | PFS is defined the time from the date of randomization to the date of disease progression or death due to any cause. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS(overall survival) | OS is defined the time between the date of randomization and the date of death. | 5 years |
| DCR | disease control rate |
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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:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Deng | Contact | +86 15802243063 | xymcdengting@126.com |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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double-blined
| Placebo |
| Drug |
placebo 5 pills po. qd continue to disease progression |
|
| up to 1 year |
| ORR | overall response rate | up to 1 year |
| Incidence of Treatment-Emergent Adverse Events | all the adverse events | through study completion, an average of 1 year |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |