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

NCT03389659 | Unknown Phase 3

• 1 other identifier: TianjinCIH20171212
• Study Type: interventional
• Target: 750
• Locations: 0 countries
• Sites: N/A

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

Keywords

mCRC; oxaliplatin plus fluoropyrimidine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• OS(overall survival)

  5 years

• DCR

  up to 1 year

• ORR

  up to 1 year

• Incidence of Treatment-Emergent Adverse Events

  through study completion, an average of 1 year

Study Arms (2)

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)

Drug: vitamin D3

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)

Drug: Placebo

Interventions

vitamin D3 DRUG

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

Vitamin D3 group

Placebo DRUG

placebo 5 pills po. qd continue to disease progression

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Ting Deng

CONTACT

+86 15802243063; xymcdengting@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blined
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 3, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share