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A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen)

A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen) - A study on taking method of Tegafur-Uracil and Leucovorin Calcium (Three times-daily regimen Versus twice-daily regimen)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005594
Enrollment
380
Registered
2011-05-18
Start date
2011-07-01
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

Colorectal cancer

Interventions

A group(three taimes-daily) UFT was administered at a dose of 300 mg/m2/day, and LV was administered at a dose of 75 mg/day. The daily doses of both UFT and LV were divided into three doses administe

Sponsors

Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically proven, Stage II, III, (Japanese Classification of Colorectal cancer 7th Ehition) primary Colorectal adenocarcinoma (eliminating appendiceal cancer). 2)Curability A 3)Age between 20 and 80 years. 4)Performance status(ECOG) of 0-1. 5)No prior therapy expect the operation. 6)Capability of oral intake 7)Patients who have satisfied the following the clinical test values within two weeks before the registration. 1.Neutrophile:>= 1,500/mm3 2.Platelet:>= 100,000/mm3 3.Hemoglobin:>= 9.0g/dL 4.Total bilirubin: < 2.0 mg/dL 5.AST, ALT: <100IU/L 6.Serum creatinine: <1.5mg/dL 8)Patient with starting the treatment within 8 weeks after operation. 9)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Active synchronous or metachronous malignancy carcinoma in situ. 2)Severe postoperative complications. 3)Severe complication. 4)Severe diarrhea. 5)Severe infectious disease. 6)Medical history of severe anaphylaxis or allergia to any drug. 7)Undergoing treatment with fluorocytosine. 8)Pregnant or lactating woman at any time during study. Men of the fertility hope. 9)Severe mental disorder. 10)Patients judged inappropriate for the study by their physicians.

Design outcomes

Primary

MeasureTime frame
3-year Disease-free survival

Secondary

MeasureTime frame
Overall survival Adverse events, Completion rate of treatment Compliance

Countries

Japan

Contacts

Public ContactMamoru Uemura

Osaka University Graduate School of Medicine Department of Surgery

muemura@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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