UMIN-CTR Clinical Trial

Basic information
Public title	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)
Acronym	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)
Scientific Title	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)
Scientific Title:Acronym	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)
Region	Japan

Condition
Condition	Resected biliary tract cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the superiority of S-1 to observation for resected biliary tract cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Relapse-free survival, Adverse events, Proporion of treatment completion, Serious adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A:Surgery alone
Interventions/Control_2	B:Surgery followed by chemotherapy with S-1
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Diagnosed as biliary tract adenocarcinoma or adenosquamous carcinoma (carcinoma of the intrahepatic bile duct (IHBD), extrahepatic bile duct (EHBD), gallbladder (GB), or ampulla of Vater (AV)) in resected specimen. The mixed-type is eligible when adenocarcinoma or adenosquamous carcinoma is dominant. 2) Pathologically diagnosed as carcinoma of the EHBD, GB and AV : T2-4, N0, M0 or T1-4, N1, M0 or carcinoma of IHBD : T1-4, N0-1, M0 according to UICC classification 3) R0 or R1 4) Aged 20 to 80 years old 5) ECOG performance status of 0 or 1 6) No distant metastases and ascites/pleural effusion according to CT or MRI after operation 7) Patients who had undergone the following surgery with D1 or more lymphadenectomy; pancreaticoduodenectomy, hepatectomy, bile duct resection, caudal lobectomy and/or cholecystectomy 8) No previous history of chemotherapy or radiotherapy for biliary tract cancer and the other malignancies. 9) Between 2 and 10 weeks after resection 10) Adequate oral intake 11) Wound after operation is healed and surgical drain is removed. 12) No watery diarrhea 13) Adequate organ functions 14) Written informed consent
Key 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
Target sample size	350

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaru Konishi
Organization	National Cancer Center Hospital East, Kashiwa
Division name	Hepatobiliary and Pancreatic Surgery
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL	04-7133-1111
Email	mkonishi@east.ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Masafumi Ikeda, Kohei Nakachi
Organization	JCOG1202 Coordinating Office
Division name	National Cancer Center Hospital East, Kashiwa Hepatobiliary and Pancreatic Medical Oncology
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL	(+81)4-7133-1111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	National Cancer Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

札幌厚生病院（北海道） 北海道大学病院（北海道） 手稲渓仁会病院（北海道）　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　 東北大学病院（宮城県） 栃木県立がんセンター（栃木県） 自治医科大学（栃木県） 埼玉県立がんセンター（埼玉県） 国立がん研究センター東病院（千葉県） 千葉県がんセンター（千葉県） 千葉大学医学部（千葉県） 国立がん研究センター中央病院（東京都） 杏林大学医学部（東京都） 国立国際医療研究センター病院（東京都） 東京女子医科大学（東京都） がん研究会有明病院（東京都） 帝京大学医学部（東京都） 東海大学医学部（神奈川県） 神奈川県立病院機構神奈川県立がんセンター（神奈川県） 北里大学医学部（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 新潟県立がんセンター新潟病院（新潟県） 富山大学附属病院（富山県） 金沢大学医学部（石川県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 近畿大学医学部（大阪府） 大阪府立病院機構大阪府立成人病センター（大阪府） 国立病院機構大阪医療センター（大阪府） 関西医科大学附属枚方病院（大阪府） 神戸大学医学部（兵庫県） 国立病院機構四国がんセンター（愛媛県）　　　　　　　　　　　　　　　　　　　　　　　　　　　　　 高知医療センター（高知県） 国立病院機構九州がんセンター（福岡県） 九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 07 Month 29 Day
Date of IRB	2013 Year 08 Month 22 Day
Anticipated trial start date	2013 Year 09 Month 09 Day
Last follow-up date	2023 Year 09 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 09 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013644