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).
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.
- 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
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