UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036542 |
|---|---|
| Receipt number | R000041524 |
| Scientific Title | Randomized Phase II study regarding treatment cycles of neo-adjuvant chemotherapy with biweekly triplet gemcitabine/cisplatin/s-1 for biliary tract cancer |
| Date of disclosure of the study information | 2019/04/19 |
| Last modified on | 2019/06/10 16:49:32 |
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Basic information
Public title
Randomized Phase II study regarding treatment cycles of neo-adjuvant chemotherapy with biweekly triplet gemcitabine/cisplatin/s-1 for biliary tract cancer
Acronym
KHBO-1902
Scientific Title
Randomized Phase II study regarding treatment cycles of neo-adjuvant chemotherapy with biweekly triplet gemcitabine/cisplatin/s-1 for biliary tract cancer
Scientific Title:Acronym
KHBO-1902
Region
| Japan |
Condition
Condition
Resectable Biliary Tract Cancers
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare resection rate in the patients biliary tract cancers who underwent 3 cycles or 6 cycles of neo-adjuvant chemotherapy with biweekly gemcitabine+cicpaltin+S1
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
Resection rate, Recurrence-free survival, Overall survival, Anti-tumor effect, Completion rate, Dose intensity, Adverse effect, Rate of LN metastasis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
3 cycles of neoadjuvant chemothrapy with biweekly gemcitabine, cisplatin, and S-1.
Interventions/Control_2
6 cycles of neoadjuvant chemothrapy with biweekly gemcitabine, cisplatin, and 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Resectable biliary tract cancer (BTC)
2) Age >= 20 y/o
3) PS 0 or 1
4) No prior treatment for BTC except for drainage
5) Proper organ function
(1) Neutrophil >= 1500/uL
(2) Platelet >= 100,000/uL
(3) Hb >= 9.0 g/dL
(4) AST and ALT <= 150 U/L
(5) Bilirubin <= 1.5 mg/dL
(6) Creatinin <= 1.2 mg/dL
(7) Creatinin clearance >= 60
6) Oral intake
7) Appropriate for neoadjuvant chemotherapy in each hospital
8) Written informed consent
Key exclusion criteria
1) Distant metastasis
2) Double cancer
3) Interstitial pneumonia
4) Waterly diarrhea
5) Active infection except for hepatitis and cholangitis
6) Several organ dysfunction (Heat failure, Renal failure, Liver failure, GI bleeding, Ileus, Uncontrolled DM)
7) Pregnancy
8) Psychic disorder
9) Allergy
10) Others
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Kobayashi |
Organization
Osaka University Hospital
Division name
Gastroenterological Surgery
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka
TEL
06-6879-3251
s-kobayashi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ioka |
Organization
KHBO
Division name
Osaka International Cancer Institute
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka City, Osaka
TEL
06-6945-1181
Homepage URL
ioka-ta@umin.ac.jp
Sponsor or person
Institute
KHBO
Institute
Department
Personal name
Funding Source
Organization
none
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
IRB of Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka City, Osaka
Tel
06-6945-1181
rinri01@opho.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041524
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