XELOX/mFOLFOX Plus Vitamin D3 vs. XELOX/mFOLFOX as Firstline Chemotherapy in mCRC

Tianjin Medical University

Status and phase: Unknown; Phase 3

Conditions: Vitamin D3

Treatments: Drug: Placebo; Drug: vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT03389659

TianjinCIH20171212

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 participants in 2 patient groups, including a placebo group

Vitamin D3 group

Experimental group

Description:

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)

Treatment:

Drug: vitamin D3

control group

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo