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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000011688 |
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Date of registration:
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09/09/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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) - 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) |
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Date of first enrolment:
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2013/09/09 |
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Target sample size:
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350 |
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Recruitment status: |
Complete: follow-up continuing |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013644 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masaru Konishi |
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Address:
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6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
Japan |
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Telephone:
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04-7133-1111 |
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Email:
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mkonishi@east.ncc.go.jp |
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Affiliation:
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National Cancer Center Hospital East, Kashiwa Hepatobiliary and Pancreatic Surgery |
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Name:
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Masafumi Ikeda, Kohei Nakachi |
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Address:
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6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
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Telephone:
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(+81)4-7133-1111 |
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Email:
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JCOG_sir@ml.jcog.jp |
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Affiliation:
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JCOG1202 Coordinating Office National Cancer Center Hospital East, Kashiwa Hepatobiliary and Pancreatic Medical Oncology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Resected biliary tract cancer
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Intervention(s)
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A:Surgery alone
B:Surgery followed by chemotherapy with S-1
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Primary Outcome(s)
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Overall survival
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Secondary Outcome(s)
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Relapse-free survival, Adverse events, Proporion of treatment completion, Serious adverse events
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Source(s) of Monetary Support
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National Cancer Center
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Ethics review
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Status: YES
Approval date: 22/08/2013
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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09/09/2023 |
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URL:
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