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

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

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.

Study Overview

• Status: Unknown
• Conditions: Vitamin D3
• Intervention / Treatment: Drug: vitamin D3; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 750
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ting Deng; Phone Number: +86 15802243063; Email: xymcdengting@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: mCRC; oxaliplatin plus fluoropyrimidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: TianjinCIH20171212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No