Phase II study of adjuvant S-1 therapy for node-positive biliary cancer

Phase II study of adjuvant S-1 therapy for node-positive biliary cancer - N-SOG 09

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010819

Enrollment

Registered

2013-06-01

Start date

2013-06-15

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

Node-positive biliary tract cancer

Interventions

TS-1 administaton after definitive surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed biliary tract cancer 2) Histologic confirmed nodal metastasis 3) Absence of distant metastatic disease and malignant ascites 4) Residual tumor status: 0 or 1 5) Age: 20-80 years 6) ECOG PS: 0 or 1 7) Entry date within 8 weeks after surgey 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Multiple cancers to be treated 2) Severe postoperative complication 3) Refractpry body cavity fluid 4) Severe co-morbidity 5) Uncontrolled diarrhea 6) History of severe drug hypersensitivity 7) Presence o dementia, or severe mental disorder 8) Not suitable for participation with any other reasons

Design outcomes

Primary

Measure	Time frame
Overall survival rate at 3 years	—

Secondary

Measure	Time frame
Reccurent free survival, overall survival, treatment completion rate, adverse event	—

Countries

Japan

Contacts

Public ContactTomoki EBATA

Nagoya University Graduated School of Medicine Division of Surgical Oncology

tomoki@med.nagoya-u.ac.jp0527442222

Outcome results

None listed

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