UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001498 |
|---|---|
| Receipt number | R000001812 |
| Scientific Title | Phase II study of TS-1 chemotherapy as adjuvant treatment after resection of hepatic metastases from colorectal cancer |
| Date of disclosure of the study information | 2008/11/12 |
| Last modified on | 2018/09/27 11:24:19 |
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Basic information
Public title
Phase II study of TS-1 chemotherapy as adjuvant treatment after resection of hepatic metastases from colorectal cancer
Acronym
Phase II study of TS-1 as adjuvant treatment after resection of hepatic metastases from colorectal cancer
Scientific Title
Phase II study of TS-1 chemotherapy as adjuvant treatment after resection of hepatic metastases from colorectal cancer
Scientific Title:Acronym
Phase II study of TS-1 as adjuvant treatment after resection of hepatic metastases from colorectal cancer
Region
| Japan |
Condition
Condition
liver metastases of colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy and safety of TS-1 as adjuvant treatment after resection of liver metastases from colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
overall survival, side effect
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 chemotherapy as adjuvant treatment
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 metastatic liver tumors of colorectal adenocarcinoma
(2) RO resection of both primary and metastatic tumor
(3) No extrahepatic metastases
(4) No prior chemotherapy (except for adjuvant chemotherapy for primary tumor)
(5)PS (ECOG): 0-1
(6)Adequate major organ function
(7)Written informed consent
Key exclusion criteria
(1) Prior chemotherapy with TS-1
(2) Multiple cancer
(3) Severe complication
(4) Active diarrhea
(5) Prebious history of severe drug-induced allergy
(6) Pregnant
(7) Disqualified by attending doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya, 466-8550, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Uehara |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
TEL
Homepage URL
kuehara@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Surgical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Division of Surgical Oncology, Nagoya University Graduate School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2008 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001812
