Phase 1b Study to Assess the Safety of Neoadjuvant TAS-102 (triFluridine/tIpiracil) with ConcurrEnt Radiation in Previously Untreated Resectable Stage II and Stage III ReCtal CancEr (FIERCE)
The study is designed to test the safety of different doses of TAS-102, the study drug, and to find out what good and bad effects it may have on participants with rectal cancer radiation.
- Age 18 years old or older.
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Stage II (T3-4aN0M0) and stage III (T1-4aN1+M0) based on MRI
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- Unresectable rectal cancer.
18 - 120
Healthy Volunteers Needed
Duration of Participation
You will receive the study drug with radiation for approximately 5.5 weeks. After chemo-radiation, the investigator will continue to watch you for side effects and follow your condition during standard FOLFOX chemotherapy for a total of 8-9 months until your standard rectal cancer surgery.
Knight Clinical Trials Information Line
Charles Lopez, MD, PhD