A randomized phase II study of UFT/LV or TEGAFOX for patient with curatively resected high risk Stage II and Stage III colorectal cancer.

A randomized phase II study of UFT/LV or TEGAFOX for patient with curatively resected high risk Stage II and Stage III colorectal cancer. - SOAC-1101

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007696

Enrollment

200

Registered

2012-04-10

Start date

2011-06-01

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

high risk stage II/ stage III colorectal cancer

Interventions

UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks. UFT(300mg/m2)+LV(75mg) /day, orally 4 weeks on and 1 week off in each corse. Total 5 weeks. Oxaliplatin giv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Confirmed adenocarcinoma 2) High risk stage II or stage III colorectal cancer 3) Recieved curative resction 4) 20 years old or older 5) PS(ECOG) 0 or 1 6) No previous treatment exclude surgery 7) Oral intake is possible 8) Adequate organ fanction 9) Treatment can start within eight weeks after surgery. 10) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Serious diarrea 2) Serious postoperative complications 3) Serious drug hypersensitivity 4) Pregnant or nursing 5) Serious coexisting illness 1; diabetes mellitus, uncontrolled or controlled with insulin 2; uncontrolled hypertension 3; liver cirrhosis 4; renal disfaunction 5; severe pulmonary dysfunction 6; active infection 7; history of myocardial infarction, unstable angina within 6 months prior to the registration 6) Active synchronous or metachronous malignancy other than carcinoma in situ 7) Sensory neuropathy 8) Severe mental disorders 9) Not suitable for participating in the study for any other reason

Design outcomes

Primary

Measure	Time frame
3-year desiese free survival rate	—

Countries

Japan

Contacts

Public ContactHideaki MIyauchi

Chiba surgical oncology development association The secretariat

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

Outcome results

None listed

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