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
A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients with Unresectable and Borderline Resectable Pancreatic Cancer.
For additional information, please contact the Research Nurses:
- Caroline DePiano, RN, MSN; 610-738-2522
- Susan Metzger, RN, MSN; 610-738-2515