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

NCT ID: NCT03389659

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2022-06-30

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.

Conditions

Vitamin D3

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D3 group

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)

Group Type: EXPERIMENTAL

vitamin D3

Intervention Type: DRUG

vitamin D3 400IU\*5pills po. qd continue to disease progression

control group

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo 5 pills po. qd continue to disease progression

Interventions

vitamin D3

vitamin D3 400IU\*5pills po. qd continue to disease progression

Intervention Type: DRUG

Placebo

placebo 5 pills po. qd continue to disease progression

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ting Deng

Role: CONTACT

xymcdengting@126.com

+86 15802243063

Other Identifiers

TianjinCIH20171212

Identifier Type: -

Identifier Source: org_study_id