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

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ClinicalTrials.gov Identifier: NCT03389659
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Vitamin D3 Drug: vitamin D3 Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blined
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-blinded, Phase III Study 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
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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)
Drug: vitamin D3
vitamin D3 400IU*5pills po. qd continue to disease progression
Placebo Comparator: 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)
Drug: Placebo
placebo 5 pills po. qd continue to disease progression


Outcome Measures

Primary Outcome Measures :
  1. PFS(progression-free survival) [ Time Frame: 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 Outcome Measures :
  1. OS(overall survival) [ Time Frame: 5 years ]
    OS is defined the time between the date of randomization and the date of death.

  2. DCR [ Time Frame: up to 1 year ]
    disease control rate

  3. ORR [ Time Frame: up to 1 year ]
    overall response rate

  4. Incidence of Treatment-Emergent Adverse Events [ Time Frame: through study completion, an average of 1 year ]
    all the adverse events


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389659


Contacts
Contact: Ting Deng +86 15802243063 xymcdengting@126.com

Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
More Information

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT03389659     History of Changes
Other Study ID Numbers: TianjinCIH20171212
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
mCRC
oxaliplatin plus fluoropyrimidine

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Oxaliplatin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antineoplastic Agents