TAS-102 With Concurrent Radiation for the Treatment of Untreated Resectable Stage II-III Rectal Cancer

Summary

This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out the safest dose of TAS-102 that can be used with radiation treatment for rectal cancer.

Timeline

Start

2019-12-11

Primary completion

2024-09-25

Completion

2026-05-31

Publications

• Results Chen EY, Nabavizadeh N, Kendsersky ND, Lessenich C, Herzig DO, Korngold E, Goodyear SM, Kennecke HF, Kardosh A, Tsikitis VL, Lu KC, Fang S, Wong M, Pegna GJ, Rocha FG, Mayo SC, Brinkerhoff B, Taber E, Rajagopalan B, Park BS, Thomas CR Jr, Lopez CD. Phase Ib Study to Assess the Safety of Neoadjuvant Trifluridine/Tipiracil With Concurrent Radiation in Resectable Stage II/III Rectal Cancer: The FIERCE Study. Clin Colorectal Cancer. 2026 Jun;25(2):249-257.e2. doi: 10.1016/j.clcc.2026.02.001. Epub 2026 Feb 4.

Drugs

Indications