Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer

Study acronym: SOLARIS
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Study completion pushed from Jul 1, 2026 to Dec 15, 2027 Show 5 more changesShow less
    • Eligibility criteria shortened, about 59 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description revised
    • Site details revised at 84 of 1031 sites
    • Publications: details revised at 1 of 1 entry
  2. Results first posted: Mar 3, 2026
    • Secondary endpoints revised (7)
    • Primary endpoint revised
    • Site details revised at 3 of 1031 sites
    v39
  3. Primary completion date changed from estimate of Jan 1, 2026 to Jul 15, 2024
    • Site details revised at 3 of 1031 sites
    v38
  4. Primary completion date: Jan 1, 2025 to Jan 1, 2026
    • Study completion date: Jul 2025 to Jul 1, 2026
    • Start date: Sep 30, 2019 to Oct 29, 2019
    • Site details revised at 3 of 1031 sites
    v37
  5. Primary completion date: Jan 1, 2024 to Jan 1, 2025
    • Study completion date: Jul 2024 to Jul 2025
    v36
Show 34 earlier versionsHide 34 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 400 to confirmed 455
    • Site details revised at 1031 of 1031 sites
    v35
  2. Study sites revised (1031)v34
  3. Study sites revised (1031)v33
  4. Study sites: 1025 to 1031v32
  5. Site details revised at 26 of 1025 sitesv31
  6. Study sites: 1011 to 1025v30
  7. Study sites: 1004 to 1011v29
  8. Study sites: 979 to 1004v28
  9. Primary completion date: May 1, 2022 to Jan 1, 2024
    • Study completion date: Jul 2022 to Jul 2024
    v27
  10. Study sites: 974 to 979v26
  11. Study sites: 967 to 974v25
  12. Study sites: 965 to 967v24
  13. Study sites: 962 to 965v23
  14. Study sites: 958 to 962v22
  15. Study sites: 951 to 958v21
  16. Study sites: 946 to 951v20
  17. Study sites: 941 to 946v19
  18. Study sites: 918 to 941v18
  19. Study sites: 895 to 918
    • Eligibility criteria expanded, about 6 words
    v17
  20. Study sites: 887 to 895v16
  21. Study sites: 882 to 887v15
  22. Study sites: 868 to 882v14
  23. Study sites: 828 to 868v13
  24. Study sites: 800 to 828v12
  25. Study sites: 777 to 800v11
  26. Study sites: 709 to 777v10
  27. Study sites: 700 to 709v9
  28. Study sites: 686 to 700v8
  29. Study sites: 634 to 686v7
  30. Study sites: 590 to 634v6
  31. Study sites: 532 to 590v5
  32. Study sites: 258 to 532v4
  33. Study sites: 110 to 258v3
  34. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 110
    • Start date changed from estimate of Sep 2019 to Sep 30, 2019
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trial studies how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab).
Trial Details
NCT Number NCT04094688
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Colorectal Adenocarcinoma
Enrollment 455 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov