Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery
Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
Sponsor: Tokyo Medical and Dental University
A PHASE3 clinical study on Colorectal Cancer, this trial is completed. The trial is conducted by Tokyo Medical and Dental University and has accumulated 8 data snapshots since 2006. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)OBJECTIVES:
Primary
* Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer.
Secondary
* Compare relapse-free and overall survival of patients treated with these regimens.
* Compare the occurrence of adverse events in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo observation.
* Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
OBJECTIVES:
Primary
* Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with curatively resected stage II colorectal cancer.
Secondary
* Compare relapse-free and overall survival of patients treated with these regimens. * Compare the occurrence of adverse events in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo observation. * Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7 days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
May 2018 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — May 2018 [monthly]
Completed PHASE3
First recorded
Oct 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Tokyo Medical and Dental University
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Ageo, Japan , Aichi-gun, Japan , Akashi, Japan , Aki-Gun, Japan , Akita, Japan , Akou, Japan , Amagasaki, Japan , Anan, Japan , Aomori, Japan , Asahi-machi, Japan and 162 more locations