This trial is examining the effectiveness and safety of short-course radiation therapy and TAS-102 (Lonsurf) plus oxaliplatin (Eloxatin) chemotherapy in rectal cancer. The main outcome to be measured will be the change in treatment response. This study is being conducted in the US.
Colorectal cancer is one of the most common cancers worldwide. A significant percentage of these patients have rectal cancer. Patients with stage 2/3 rectal cancer, are at moderate to high risk of developing an advanced disease or to recur (when cancer comes back) after treatment. Treatment before surgery helps to downsize the tumor. This decreases the chances of leaving cancer cells behind after surgery which is what causes recurrence and/or spread cancer.
TAS-102 (trifluridine–tipiracil) is an oral anti-cancer drug that shows to have a positive effect on survival in patients with rectal cancer. It also showed effectiveness when combined with oxaliplatin to treat advanced colorectal cancer.
This trial is examining the effectiveness of a short course of radiotherapy (RT) followed by TAS-102 and oxaliplatin (TASOX) before rectal cancer surgery. The main outcome to be measured is the downgrading of rectal cancer before surgery.
Who are they looking for?
This trial will be recruiting 27 participants with stage 2 or 3 rectal cancer that can be surgically removed. These patients must have adequate blood levels, liver and kidney function, and a negative pregnancy test.
Patients must not have evidence of cancer spread, bowel blockages, or any other severe disorder, chemotherapy treatment within the last 5 years, or pelvic radiation.
How will it work
All participants will be treated with short-course radiation followed by 6 2-week cycles of TASOX followed by rectal surgery. TAS-102 will be given orally over days 1 to 5 and oxaliplatin by injection over 2 hours on day 1. Participants will be followed for 6 months.
The main outcome to be measured will be the change in tumor size before surgery.