A021703

A021703 Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)]

ClinicalTrials.gov Identifier: NCT04094688

This trial is part of the Community Oncology Research Program (NCORP), which is sponsored by the National Cancer Institute (NCI).

Purpose:

The purpose of this study is to compare the usual treatment (usual chemotherapy plus bevacizumab) plus high-dose vitamin D3 to using the usual treatment plus regular-dose vitamin D3.  Study doctors will be looking to see if the addition of high-dose vitamin D3 to the usual approach can shrink or stabilize tumors for a longer period of time than regular-dose vitamin D3 and usual approach.

Treatment Arms:

  • High Dose Vitamin D3 Arm
    MFOLFOX6 or FOLFIRI + Becacizumab+High-Dose Vitamin D3
  • Standard Dose Vitamin D3 Arm
    MFOLFOX6 or FOLFIRI + Becacizumab+Standard-Dose Vitamin D3

Follow-Up:

Participants will be followed for 5 years from the date of registration.

Partial Eligibility Criteria:

  • Advanced metastatic colorectal adenocarcinoma with no surgery planned
  • No prior systemic treatment for metastatic disease
  • No continuous use of vitamin D supplements > 2000 IU per day for 12 months prior to registration.  

For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515
Share This Page: