UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011688 |
|---|---|
| Receipt number | R000013644 |
| 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) |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2021/01/05 16:25:32 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013644
