Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer

Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer - Phase II study of adjuvant therapy of alternate day oral therapy with S-1 for patients with curative resected biliary tract cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021459

Enrollment

Registered

2016-03-25

Start date

2016-03-25

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

biliary tract cancer

Interventions

S-1 80mg/m2/day is orally administered twice a day for adjuvant therapy. This therapy is administerd alternate day for 1 year.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer which is pathologically proven diagnosis of adenocarcinoma. 2) Biliary tract cancer which is curatively resected(R0 or R1) 3)with no distant metastasis, cancerous ascites 4) Age of more than 20 years 5) ECOG performance status (PS) of 0 to 1 6) No therapy without surgery for biliary tract cancer 7) No postoperative complications and possible to start treatment within 10 weeks from operation 8) Adequate organ function WBC: >=2,500/mm3 and <=12,000/mm3 Neut:>=1,500/mm3 Platelet: >=100,000/mm3 sT.bil: <=2.0mg/dl AST, ALT: <= 100IU/L Cre <= 1.2mg/dL 9) oral intake 10)written informed consent

Exclusion criteria

Exclusion criteria: 1) administration contraindication of TS-1 2)Regular use of frucitocin, fenitoin, warfarin 3) Severe infection 4) Intestinal pneumonia or lung fibrosis 5) Severe diarrhea 6) Severe complication 7) History of other active malignancy 8) Pregnancy or the desire to preserve fecundity 9) Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Countries

Japan

Contacts

Public ContactYuichi Nagakawa

Tokyo Medical University gastrointestinal and pediatric surgery

naga@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

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