This trial is examining the effectiveness of circulating cell-free tumor DNA (cCFTD) as a predictive factor for the treatment of advanced colorectal cancer with regorafenib (Stivarga) or TAS-102. The main outcome to be measured will be to evaluate the ability of early change of cCFTD after the start of the treatment. This trial will be conducted in Texas, US.
Colorectal cancer is the third most common cancer in the US. Some patients present metastatic disease (spread to other parts of the body) at diagnostic. The standard treatment is chemotherapy and surgery. However, chemotherapy has only a limited effect in these patients. Targeted therapy such as regorafenib can also be used. Regorafenib and TAS-102 (Lonsurf) may stop the growth of tumor cells by blocking some of the proteins needed for cell growth.
cCFTD is a blood test used to monitor tumor growth during treatment. However, it is still not clear if cCFTD could be used to predict the treatment outcomes.
This trial is examining the effectiveness of cCFTD as a predictive factor for the treatment of advanced colorectal cancer with regorafenib or TAS-102. The main outcome will be measured as the change in cCFTD in blood and tumor progression.
Who are they looking for?
This trial is recruiting 100 participants with advanced colorectal cancer with at least 2 prior treatment failures. Patients should agree to return for follow-up visits and to give blood samples for testing.
Patients should not have another severe disease or active infection and should not have brain metastasis. Patients should also not be pregnant or breastfeeding. Patients with end-stage kidney disease on dialysis or those unable to swallow pills will be excluded.
How will it work
These will be two groups. In group 1, patients will undergo cCFTD testing. Patients will then receive either receive regorafenib on days 1 to 21 and TAS-102 on days 1 to 5 and 8 to 12 or standard treatment with regorafenib or TAS-102. Treatment repeats every 28 days in the absence of disease progression or toxicity. Group 2 will receive regorafenib or TAS-102 as per standard of care. Patients will be followed up for up to 18 months.