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Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer.

Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer. - Feasibility trial of UFT after withdrawal of adjuvant TS-1 with adverse effects in patients with curatively resected gastric cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001148
Enrollment
40
Registered
2008-05-07
Start date
2008-05-01
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

Gastric Cancer

Interventions

UFT:300-600 mg/body/day Day 1-5 One course takes 7 days. In total of one year administration of UFT and TS-1

Sponsors

Division of Gastrointestinal Surgery, Kobe University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histological proven gastric carcinoma D>=2 lymph node dissection and curability A or B stage II/III(except for T1) Age 20-80 years Despite adjust dose and regimen, duration of TS-1 is less than 6 months caused by adverse effects. within 1-7 weeks after dropping TS-1 Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. Written informed consent.

Exclusion criteria

Exclusion criteria: administration contraindication of UFT Severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) Severe watery diarrhea. HIV+ Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.

Design outcomes

Primary

MeasureTime frame
Feasibility

Secondary

MeasureTime frame
Safety of UFT Relapse-Free Survival Overall Survival

Countries

Japan

Contacts

Public ContactTakashi Kamigaki

Kobe University Graduate School of Medicine Division of Gastrointestinal Surgery

078-382-5925

Outcome results

None listed

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