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

Vitamin D3 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03389659
• Other study ID #: TianjinCIH20171212
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 14, 2017
• Last updated: December 27, 2017
• Start date: February 2018
• Est. completion date: June 2022

Study information

• Verified date: December 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Ting Deng
• Phone: +86 15802243063
• Email: xymcdengting[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D3

Intervention

Drug:
• vitamin D3
vitamin D3 400IU*5pills po. qd continue to disease progression
• Placebo
placebo 5 pills po. qd continue to disease progression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OS(overall survival)	OS is defined the time between the date of randomization and the date of death.	5 years
Secondary	DCR	disease control rate	up to 1 year
Secondary	ORR	overall response rate	up to 1 year
Secondary	Incidence of Treatment-Emergent Adverse Events	all the adverse events	through study completion, an average of 1 year