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

NCT04104139 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-04-15

No results posted yet for this study

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.

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

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D-CRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

DRUG

Trifluridine and Tipiracil Hydrochloride

Given PO

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Charles D Lopez, MD, PhD · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2024-09-25
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104139 on ClinicalTrials.gov