UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036449 |
|---|---|
| Receipt number | R000041509 |
| Scientific Title | Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy |
| Date of disclosure of the study information | 2019/04/17 |
| Last modified on | 2023/06/05 14:21:32 |
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Basic information
Public title
Randomized Phase II study of adjuvant chemotherapy with gemcitabine plus cisplatin versus gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy(KHBO1901)
Acronym
Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy
Scientific Title
Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy
Scientific Title:Acronym
KHBO1901
Region
| Japan |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the efficacy for GC and GS as adjuvant chemotherapy in patients with BTC undergoing curative resection without major hepatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Recurrence-free survival (2-year recurrence-free survival rate)
Key secondary outcomes
1)Overall survival
2)Proportion of treatment completion
3)Relative dose intensity
4)Proportion of adverse events
5)Relapse-free survival rate and overall survival of lymph node positive/lymph node negative case
6)Relapse-free survival rate and overall survival of R0/R1 case
7)Relapse-free survival rate and overall survival of each primary site
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Adjuvant GC chemotherapy consisted of
intravenous GEM(1000mg/mm2) and CDDP (25mg/m2) on days 1 and 8, with 1 week rest.
Interventions/Control_2
Adjuvant GS chemotherapy consisted of
intravenous GEM(800mg/mm2) on days 1 and 8, and oral S-1(50mg/mm2/day) administered
twice daily on days 1-14, with a 1 week rest.
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) Diagnosed as having biliary tract adenocarcinoma or adenosquamous carcinoma(IHBD, EHBD, GB or AV cancer) in resected specimen.
2) R0 or R1 residual disease.
3) Pathological disease stage according to the UICC classification, seventh Edition: T2-4, N0, M0 or T1-4, N1, M0 (for patients with EHBD, GB or AV cancer), or T1-4, N0-1, M0 (for patients with IHBD cancer).
4) Age over 20 years
5) ECOG performance status 0 or 1
6)No treatment other than surgery except of drainage
7) No distant metastasis according to the radiological findings after operation.
8) Adequate organ functions
a) Neutrophil count >=1,500/mm3
b) Platelet count >= 100,000/mm3
c) Serum aspartate transaminase <=150U/l
d) Serum alanine transaminase <=150U/l
e) Serum total bilirubin <=1.5 mg/dl
f) Serum creatinine <=1.2 mg/dl
g) Creatinine clearance >=60 ml/min
9) Adequate oral intake.
10) Between 3 and 12 weeks after resection.
11) Written informed consent.
Key exclusion criteria
1)Distant metastasis except of positive CY
2) Not performed lobectomy
3) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease-free interval of 3 years or shorter, excluding lesions consistent with intraepithelial cancer, i.e., intramucosal cancer that are assessed as cured by endoscopical treatment.)
4) Patients with a history of severe drug hypersensitivity or drug allergy.
5) Serious complicating disorders (Interstitial pneumonia, pulmonary fibrosis or severe emphysema, hepatic cirrhosis, uncontrollable-diabetes, cardiac disease, renal failure, liver failure, hemorrhagic peptic ulcer etc).
6) Active infection requiring systemic therapy
7) Pregnant or lactating women, women with childbearing potential, males males who wish a pregnancy of his partner.
8) Severe psychiatric disease.
9) Inappropriate for this study judged by the attending physician
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Yanagimoto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-biliary-pancreatic surgery, Department of Surgery
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
yanagimh@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ioka |
Organization
Kansai Hepato-Biliary Oncology Group (KHBO)
Division name
Department of Cancer Survey and Gastrointestinal Oncology,Osaka International Cancer Institute
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka-shi, Osaka , Japan
TEL
06-6945-1181(6383)
Homepage URL
ioka-ta@umin.ac.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group (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
Institutional Review Board of Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan.
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 | 17 | 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
| 2019 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 22 | 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 | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041509
