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Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer - Investigation of risk facter for colon cancer-

Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer - Investigation of risk facter for colon cancer- - Phase II trial of DIF drug as adjuvant therapy after curative resection of colon cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003252
Enrollment
120
Registered
2010-03-01
Start date
2008-07-01
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

Colon cancer

Interventions

UFT/LV UFT 300mg/m2/day LV 750mg/day for 28 days followed by a 7-day rest period (one cycle=5 weeks)X5 cycle or TS-1 80mg/m2/day for 28 days followed by a 14-day rest period (one cycle = 6 we

Sponsors

Yamaguchi University Department of Srgery and Clinical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histopathologically proven colon cancer 2) pathological stage 2 (high risk),3 3) resection of histological curability A was performed 4) ECOG PS 0-2 5) 20-80 years old 6) no prior chemotherapy and radiotherapy 7) adequate organ function 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Contraindications of using UFT, LV, TS-1 2) active double cancer except ca. in situ 3) Severe postoperative complication 4) Serious coexisting illness a)uncontrolled diabetes mellitus b)uncontrolled hypertension c)history of myocardial infarction, unstable angina within 6 months prior to the registration severe d)liver cirrhosis e)pulmonary dysfunction 5) pregnant or nursing patient or with intent to bear baby 6) mental disorder or psychiatric symptom 7) HIV infection 8) Disqualified by attending doctor

Design outcomes

Primary

MeasureTime frame
Relapse free survival

Secondary

MeasureTime frame
Overall survival,Compliance, Relation of risk facter, Measurement of anticancer drug-sensitive facter

Countries

Japan

Contacts

Public ContactTadahiko Enoki

Yamaguchi University Department of Surgery and Clinical Science

surg-1@yamaguchi-u.ac.jp0836-22-2261

Outcome results

None listed

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