Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer

Randamised phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resectable bile duct cancer - Bile Duct Cancer Adjuvant Trial (BCAT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000820

Enrollment

300

Registered

2007-09-10

Start date

2007-09-01

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

Bile duct cancer

Interventions

Adjuvant chemoterapy with gemcitabine Observation following surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adenocarcinoma; Extrahepatic bile duct carcinoma or hilar type intrahepatic cholangiocarcinoma 2. UICC stage I or II or III, R0 or R1 3. ECOG PS 0 or 1 4. No chemotherapy or radiotherapy in the past 5 years 5. 3000/mm3<=WBC<=12000/mm3, Plt>=100000/mm3, Hb=>8.0 g/dL, T.Bil<=2.0mg/dL, AST<=100IU/L, ALT<=100IU/L, Cre<=1.5mg/dL

Exclusion criteria

Exclusion criteria: 1. Pleural effusion or ascites, moderate amount 2. Pericardial effusion 3. NYHA class III or IV 4. Myocardiac infarction in the past 3 months 5. Active viral hepatitis 6. Uncontrolled Diabetes Melitus 7. Blood trasfusion in the past 2 weeks

Design outcomes

Secondary

Measure	Time frame
Adverse Events, Recurrence Free Survival Time	—

Primary

Measure	Time frame
Over All Survival Time	—

Countries

Japan

Contacts

Public ContactTomoki Ebata

Nagoya University, Graduate School of Medicine Divison of Surgical Oncology

tomoki@med.nagoya-u.ac.jp

Outcome results

None listed

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