Study of 5FU/LV with Regorafenib for Metastatic Colorectal Cancer
This study is looking at how well a combination of medicines, 5-Fluorouracil/Leucovorin (5FU/LV) and Regorafenib, works for people with metastatic colorectal cancer (cancer that has spread). This treatment is for patients whose cancer has not responded to at least two previous treatments. You would be randomly assigned to receive either 5FU/LV with Regorafenib or a different combination of medicines, Trifluridine-tipiracil and Bevacizumab. The study aims to see if the 5FU/LV and Regorafenib combination is as effective as the other treatment in controlling the cancer, and how safe it is. We are looking for about 57 participants aged 18 or older with confirmed metastatic colorectal cancer and a good general health status.
- Study design
- This is a randomized phase II study with 57 participants. You would be randomly assigned to one of two treatment groups.
- What's involved
- Treatment will continue until the disease progresses, side effects are too severe, or you withdraw, for up to 12 cycles of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be assessed from the start of treatment until progression, unacceptable side effects, or withdrawal, for up to 18 months.
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5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With Metastatic Colorectal Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Maen Abdelrahim, MD, PhD, Pharm D · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute
- Abdullah Esmail, MD · STUDY_DIRECTOR · Houston Methodist Neal Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Efficacy of 5FU/LV in combination with regorafenib in metastatic colorectal cancerFrom date of initial treatment until progression, unacceptable toxicity, treating physician's discretion, or patient withdraws, whichever comes first, assessed up to 18 months.
Overall survival rate of patients with metastatic colorectal cancer treated with 5FU/LV in combination with regorafenib at 12 months.