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Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer

Randomized phase II study of dose schedule of TS-1 for resected Colorectal Cancer - Study of Alternate-day administrations of TS-1 for resected Colorectal Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013185
Enrollment
170
Registered
2014-02-18
Start date
2014-04-01
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

Standard Arm(Daily administrations) TS-1 is administered orally for 28 days, followed by 14 days rest. Administrations are conducted for 24 weeks from the date of the start of the therapy. After the

Sponsors

Clinical Study Group of Osaka (CSGO), Colorectal Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically proven, Stage III, (Japanese Classification of Colorectal cancer 8th Edition) primary Colon cancer or RS. 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 clinical test values within 14 days before the registration. 8)Patient with starting the treatment within 8 weeks after operation. 9)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Active double cancer 2)Synchronous or metachronous malignancy other than carcinoma in situ. 3)Severe postoperative complications. 4)Severe complication. 5)Severe diarrhea. 6)Severe infectious disease. 7)Medical history of severe anaphylaxis or allergia to any drug. 8)Undergoing treatment with fluorocytosine. 9)Hepatitis B virus infection, hepatitis C virus infection. 10)Women who are pregnant or breast-feeding, or Women who may become pregnant and fertile men. 11)Severe mental disorder. 12)Patients judged inappropriate for the study by their physicians.

Design outcomes

Primary

MeasureTime frame
Treatment Completion Rate

Secondary

MeasureTime frame
3-year Disease-Free Survival Overall Survival Compliance Safety

Countries

Japan

Contacts

Public ContactTaishi Hata

Osaka University Graduate School of Medicine Gastroenterological Surgery

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

Outcome results

None listed

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