A randomized clinical trial of adjuvant chemotherapy with TS-1 versus UFT following curative operation for Stage III colorectal cancer

A randomized clinical trial of adjuvant chemotherapy with TS-1 versus UFT following curative operation for Stage III colorectal cancer - A randomized study of TS-1 versus UFT as adjuvant therapy in patients with Stage III colorectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000346

Enrollment

200

Registered

2006-04-01

Start date

2005-07-01

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

stage III colorectal cancer

Interventions

UFT 400mg/m2/day 5days' medication, 2days' rest Start medication within 6weeks postoperatively, continue for 12months TS-1 80mg/m2/day 28days' medication, 14days' break Start medication withi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: :curatively resected stage III colorectal adenocarcinomas :performance status 0/1 :no serious postoperative complications :age not less than 20, not more than 80 :no past history of preoperative treatments, e.g.chemother or radiother. :written informed consent

Exclusion criteria

Exclusion criteria: :patients with hypersensitivity or allergy to any medicine :Pts. with myelosupression, renal dysfuction, or liver dysfuncion :Pts. with severe postoperative complications :Pt. who is pregnant or is to be pregnant :Pts. with multiple cancers :Pts. who are taking other fluoropyrimidine derivatives :Pts. with severe infection or inflammation :doctor's decision for exclusion

Design outcomes

Primary

Measure	Time frame
3-year disease free survival	—

Secondary

Measure	Time frame
overall survival	—

Countries

Japan

Contacts

Public ContactKeiji Koda

Boso Clinical Oncology Group The nonprofit organization

k-koda@umin.ac.jp043-293-0086

Outcome results

None listed

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