A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer

A randomized phase II trial of adjuvant chemotherapy with UFT/LV versus S-1 following curative resection for stage III colorectal cancer - A randomized phase II trial of UFT/LV versus S-1 adjuvant therapy in patients with stage III colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001560

Enrollment

140

Registered

2008-12-10

Start date

2008-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stage III colorectal cancer

Interventions

UFT 300mg per m2 per day and LV 75mg per day for 28 days every 5-weeks for 6 months TS-1 80mg per m2 per day for 28 days every 6-weeks for 12 months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological Stage III colorectal adenocarcinoma 2. Resection of histological curability A was performed 3. 20-80 years old 4. No prior chemotherapy and radiotherapy 5. Performance status(ECOG):0 or 1 6. Sufficient organ functions 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe postoperative complication 2. Serious coexisting illness 1)uncontrolled diabetes mellitus and hypertension 2)history of myocardial infarction, unstable angina within 6 months prior to the registrationsevere 3)pulmonary dysfunction 3. Active diarrhea 4. Multiple cancer 5. Pregnant 6. Disqualified by attending doctor

Design outcomes

Primary

Measure	Time frame
3-year disease free survival rate	—

Secondary

Measure	Time frame
overall survival	—

Countries

Japan

Contacts

Public ContactHideaki Miyauchi

Graduate school of medicine Department of frontier surgery

miyahide@faculty.chiba-u.jp043-226-2109

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026