UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010819 |
|---|---|
| Receipt number | R000012372 |
| Scientific Title | Phase II study of adjuvant S-1 therapy for node-positive biliary cancer |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2022/06/08 17:37:51 |
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Basic information
Public title
Phase II study of adjuvant S-1 therapy for node-positive biliary cancer
Acronym
N-SOG 09
Scientific Title
Phase II study of adjuvant S-1 therapy for node-positive biliary cancer
Scientific Title:Acronym
N-SOG 09
Region
| Japan |
Condition
Condition
Node-positive biliary tract cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of adjuvant chemotheraphy for node-positive biliary tract cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival rate at 3 years
Key secondary outcomes
Reccurent free survival, overall survival, treatment completion rate, adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TS-1 administaton after definitive surgery
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed biliary tract cancer
2) Histologic confirmed nodal metastasis
3) Absence of distant metastatic disease and malignant ascites
4) Residual tumor status: 0 or 1
5) Age: 20-80 years
6) ECOG PS: 0 or 1
7) Entry date within 8 weeks after surgey
8) Written informed consent
Key exclusion criteria
1) Multiple cancers to be treated
2) Severe postoperative complication
3) Refractpry body cavity fluid
4) Severe co-morbidity
5) Uncontrolled diarrhea
6) History of severe drug hypersensitivity
7) Presence o dementia, or severe mental disorder
8) Not suitable for participation with any other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | NAGINO |
Organization
Nagoya University Graduated School of Medicine
Division name
Division of Surgical Oncology
Zip code
466-8550
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | EBATA |
Organization
Nagoya University Graduated School of Medicine
Division name
Division of Surgical Oncology
Zip code
466-8550
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
0527442222
Homepage URL
tomoki@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Surgical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
Tel
0527442217
tomoki@med.nagoya-u.ac.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
名古屋大学附属病院（愛知県）ほか
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1245/s10434-020-08355-3
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1245/s10434-020-08355-3
Number of participants that the trial has enrolled
50
Results
The diseases included perihilar cholangiocarcinoma (n=23), distal cholangiocarcinoma (n=20), and gallbladder cancer (n=7). The median number of examined and positive lymph nodes were 14.5 and 2. Few patients experienced grade 3 or 4 adverse events. The protocol treatment was completed by 32 patients. The median RDI was 87.5%. 3 years OS and RFS rate were 50% and 32%. The OS for the patients with four or more positive lymph nodes was significantly worse than for those with one to three positive lymph nodes.
Results date posted
| 2022 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male: n=34
Median age: 70 years old
Tumor location
perihilar cholangiocarcinoma: n=23
distal cholangiocarcinoma: n=20
gallbladder cancer: n=7
Participant flow
The trial enrolled 51 patients from 11 participating hospitals between June 2013 and April 2016. One patient who had a disease relapse before initiation of the treatment
protocol was excluded from the trial. The remaining 50 patients formed the study cohort.
Adverse events
No patients experienced grade 4 adverse events. The most frequent grade 3 hematologic toxicity was abnormal neutrophil and hemoglobin levels, occurring in two patients each, followed by abnormal platelets levels in one patient. Nonhematologic toxicities of grade 3 included anorexia, edema, and gastrointestinal hemorrhage, each occurring in one patient.
Outcome measures
3 years overall survival rate: 50%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 04 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2022 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012372
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