A phase III trial of S-1 vs. observation in patients with resected biliary tract cancer ASCOT : Adjuvant S-1 for CholangiOcarcinoma Trial (JCOG1202, ASCOT)

Phase 3

• Conditions: Resected biliary tract cancer

• Registration Number: JPRN-UMIN000011688
• Lead Sponsor: Japan Clinical Oncology Group (JCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-09
• Study Completion: 2023-09-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancy except carcinoma in situ or intramucosal tumor curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Impossible to use both iodine and gadolinium due to being allergic to contrast agent 4) Fever of 38 degrees Celsius or over 5) Pregnant or lactating women or women of childbearing potential, male expecting partner's pregnancy 6) Severe psychiatric disease 7) Poorly controlled diabetes mellitus 8) Poorly controlled hypertension 9) Unstable angina pectoris within 3 weeks or with a history of myocardial infarction within 6 months 10) Patients requiring flucytosine, phenytoin or warfarin 11) Interstitial pneumonia, pulmonary fibrosis or severe emphysema

Study & Design

• Study Type: Interventional
• Study Design: Not specified