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

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.

NCT Number	NCT04104139
Lead Sponsor	OHSU Knight Cancer Institute Collaborators: Oregon Health and Science University, Taiho Pharmaceutical Co., Ltd.
Conditions	Rectal Adenocarcinoma, Stage IIA Rectal Cancer AJCC v8, Stage IIB Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Rectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Rectal Cancer AJCC v8
Enrollment	19 participants
Start Date	2019-12-11
Primary Completion	2024-09-25 (estimated)
Study Completion	2025-07-15 (estimated)
Updated on ClinicalTrials.gov	2026-08-06