IRB #

STUDY00019576

Title

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)

Principal Investigator

Charles Lopez

Study Purpose

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.

Medical Condition(s)

Rectal Cancer

Eligibility Criteria

Inclusion:
- 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

Exclusion:
- Unresectable rectal cancer.

Age Range

18 - 120

Healthy Volunteers Needed

No

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.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Charles Lopez, MD, PhD

Recruitment End

03/02/2026

Compensation Provided

No


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