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)

UMIN ID: UMIN000011688

Registered date:09/09/2013

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Resected biliary tract cancer
• Date of first enrollment: 2013/09/09
• Target sample size: 350
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A:Surgery alone
B:Surgery followed by chemotherapy with S-1

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Relapse-free survival, Adverse events, Proporion of treatment completion, Serious adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Clinical Oncology Group (JCOG)
• Source(s) of Monetary Support: National Cancer Center