NIPH Clinical Trials Search

UMIN ID: UMIN000011688

Registered date:09/09/2013

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)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedResected biliary tract cancer
Date of first enrollment2013/09/09
Target sample size350
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A:Surgery alone B:Surgery followed by chemotherapy with S-1


Primary OutcomeOverall survival
Secondary OutcomeRelapse-free survival, Adverse events, Proporion of treatment completion, Serious adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Masafumi Ikeda, Kohei Nakachi
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
Telephone (+81)4-7133-1111
Affiliation JCOG1202 Coordinating Office National Cancer Center Hospital East, Kashiwa Hepatobiliary and Pancreatic Medical Oncology
scientific contact
Name Masaru Konishi
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan Japan
Telephone 04-7133-1111
Affiliation National Cancer Center Hospital East, Kashiwa Hepatobiliary and Pancreatic Surgery