Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy

Study acronym: DARENCA4
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Minor Trial completed Show 6 more changesShow less
    • Final enrollment: 84 participants (planned 100)
    • Study completion date changed from estimate of Sep 1, 2029 to Sep 22, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 12 entries
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 1 of 1 entry
  2. Minor Primary completion date: Dec 20, 2026 to Sep 1, 2026
    • Study completion date: Dec 20, 2028 to Sep 1, 2029
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Notable Lead sponsor: Frede Donskov to Niels Fristrupv4 Show 4 more changesShow less
    • Primary completion date: Dec 20, 2021 to Dec 20, 2026
    • Study sites: 3 to 2
    • Study completion date: Dec 20, 2022 to Dec 20, 2028
    • Study description revised
  5. Notable Primary completion date: Dec 20, 2019 to Dec 20, 2021
    • Study completion date: Dec 20, 2020 to Dec 20, 2022
    v3
  6. Minor Site contacts updated at 1 of 3 sitesv2
  7. 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.
FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)
Trial Details
NCT Number NCT03581773
Lead Sponsor Niels Fristrup
Conditions
(from sponsor)
Mucositis, Stomatitis
Related terms Mucositis, Stomatitis
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov