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5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Interventions: 5FU/LV (Drug), Bevacizumab (Drug), Regorafenib (BAY 73-4506) (Drug), Trifluridine-tipiracil (Drug) to 5FU/LV (Drug), Bevacizumab (Drug), Regorafenib (BAY 73-4506) (Drug), Trifluridine-tipiracil (Drug) · Eligibility criteria expanded, about 21 words · Secondary endpoints: details revised at 3 of 3 entries · 1 more Show 4 more changesShow less
    • Interventions: 5FU/LV (Drug), Bevacizumab (Drug), Regorafenib (BAY 73-4506) (Drug), Trifluridine-tipiracil (Drug) to 5FU/LV (Drug), Bevacizumab (Drug), Regorafenib (BAY 73-4506) (Drug), Trifluridine-tipiracil (Drug)
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 18 of 19 entries
  2. Enrollment target: 56 to 57 Eligibility criteria shortened, about 130 wordsv4 Show 1 more changeShow less
    • Eligibility criteria shortened, about 130 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 2025 to May 8, 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of May 2025 to May 8, 2025
    • Site details revised
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 is a non-inferiority randomized phase II trial investigating the efficacy and safety of 5FU/LV in combination with regorafenib for patients with metastatic colorectal cancer in the third-line setting. Patients will be randomly assigned in a 2:1 ratio between 5FU/LV combined with regorafenib or trifluridine-tipiracil (FTD-TPI) plus bevacizumab. Arm 1 (Treatment Arm) will consist of the 5FU/LV administered to 38 patients as (LV \[400 mg/m² IV over 120 minutes\], followed by 5FU \[400 mg/m² IV bolus then 2400 mg/m² IV infusion over 46 hours\] in 2-week cycles) and regorafenib will be administered dose of 80-120 mg per day with weekly 40 mg per day increases to a maximum of 120 mg per day for 3 weeks on /1 week off until disease progression, up to 12 cycles of treatment. Arm 2 (Control Arm) received by an additional 19 patients, will be given as FTD-TPI, administered orally, BID, at a starting dose of 35 mg/m2 of body-surface area, on days 1 through 5 and on days 8 through 12 every 28 days. Bevacizumab, at a dose of 5 mg per kilogram of body weight, will be administered intravenously on days 1 and 15. The 28-day treatment cycle continued until disease progression or unacceptable toxic effects occurred or consent was withdrawn, up to 12 cycles of treatment.
Trial Details
NCT Number NCT06887218
Lead Sponsor The Methodist Hospital Research Institute
Conditions Metastatic Colorectal Cancer (CRC)
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov