UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045156 |
|---|---|
| Receipt number | R000051586 |
| Scientific Title | Analysis of a multicenter, prospective non-interventional study of chemotherapy in elderly patients with biliary tract cancer (JON2104-B) |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2024/02/15 18:10:31 |
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Basic information
Public title
Analysis of a multicenter, prospective non-interventional study of chemotherapy in elderly patients with biliary tract cancer (JON2104-B)
Acronym
Analysis of a multicenter, prospective non-interventional study of chemotherapy in elderly patients with biliary tract cancer (JON2104-B)
Scientific Title
Analysis of a multicenter, prospective non-interventional study of chemotherapy in elderly patients with biliary tract cancer (JON2104-B)
Scientific Title:Acronym
Analysis of a multicenter, prospective non-interventional study of chemotherapy in elderly patients with biliary tract cancer (JON2104-B)
Region
| Japan |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the current status of chemotherapy regimen selection in clinical practice and to evaluate the efficacy and safety of combination chemotherapy in patients aged 70 years or older with advanced biliary tract cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 70 years or older
2) Clinically and radiologically diagnosed as biliary tract cancer (carcinoma of perihilar bile duct, distal extrahepatic bile duct, gallbladder, ampulla of Vater and intrahepatic bile duct).
3) Pathologically diagnosed adenocarcinoma or adenosquamous carcinoma
4) Unresectable or recurrent biliary tract cancer
5) Scheduled to receive chemotherapy with GC, GS, GCS, GEM, or S-1*
6) No previous radiation therapy or chemotherapy for biliary tract cancer
7) Capable of assessing geriatric assessment (G8, IADL)
8) Written informed consent
9) No malignancy under treatment (prostate and breast cancers treated only with endocrine therapy are eligible).
*GC (gemcitabine + cisplatin), GS (gemcitabine + S-1), GCS (gemcitabine + cisplatin + S-1), GEM (gemcitabine)
Key exclusion criteria
none
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Furuse |
Organization
Kanagawa Cancer Center
Division name
Department of gastroenterology
Zip code
241-0815
Address
2-3-2, Nakao, Ashahi-ku, Yokohama, Kanagawa, 241-0815, Japan
TEL
+81-45-520-2222
jfuruse@hotmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Nakachi |
Organization
Tochigi Cancer Center
Division name
Medical Oncology
Zip code
320-0834
Address
4-9-13, Yohnan, Utsunomiya, Tochigi,320-0834, Japan
TEL
028-658-5151
Homepage URL
knakachi@tochigi-cc.jp
Sponsor or person
Institute
Japan Oncology Network in Hepatobiliary and Pancreas
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Cancer center
Address
6-20-2, Shinkawa, Mitaka, Tokyo, 181-8611, Japan
Tel
+81-45-520-2222
knakachi@tochigi-cc.jp
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
神奈川県立がんセンター
栃木県立がんセンター
杏林大学医学部
大阪国際がんセンター
高知医療センター
高崎総合医療センター
新潟県立がんセンター新潟病院
石川県立中央病院
聖隷浜松病院
兵庫県立がんセンター
京都大学医学部附属病院
埼玉県立がんセンター
国立がん研究センター中央病院
国立がん研究センター東病院
近畿大学
日本大学医学部付属板橋病院
国際医療福祉大学熱海病院
金沢大学附属病院
鹿児島市立病院
千葉県がんセンター
福島県立医科大学
千葉大学医学部附属病院
武蔵野赤十字病院
宮崎大学医学部附属病院
山口大学
鹿児島大学病院
札幌医科大学
東海大学病院
四国がんセンター
大阪市立総合医療センター
静岡県立静岡がんセンター
東北大学病院
聖マリアンナ医科大学
九州大学病院
東京医科大学
がん研究会有明病院
和歌山県立医科大学
香川大学医学部附属病院
国際医療研究センター病院
国立病院機構大阪医療センター
岡山大学病院
京都府立医科大学
国際医療福祉大学成田病院
旭川医科大学
愛媛県立中央病院
手稲渓仁会病院
北海道大学病院
神戸大学大学付属病院
静岡県立総合病院
浜松医科大学
九州がんセンター
東京都健康長寿医療センター
松山赤十字病院
東京都立多摩総合医療センター
横浜市立大学附属病院
大阪労災病院
富山大学
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 16 | 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
305
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
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of a multicenter, prospective non-interventional study of chemotherapy in elderly patients with biliary tract cancer
Management information
Registered date
| 2021 | Year | 08 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051586
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| Registered date | File name |
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