UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006487 |
|---|---|
| Receipt number | R000007697 |
| Scientific Title | Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies |
| Date of disclosure of the study information | 2011/10/06 |
| Last modified on | 2016/11/16 08:56:41 |
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Basic information
Public title
Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Acronym
Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
<CCOG-1103 (C3-01)>
Scientific Title
Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Scientific Title:Acronym
Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
<CCOG-1103 (C3-01)>
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity
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
S-1 monotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Histopathologically confirmed colorectal cancer
(2) Unresectable advanced colorectal cancer patients who have failed prior oxaliplatin and irinotecan-based therapies
(3) Measurable or evaluable disease (RECIST ver.1.1.)
(4) Colorectac cancer with Kras mutant type gene
(5) Age of 20 years or older
(6) ECOG performance status 0-1
(7) Alife expectancy greater than 3 months
(8) Written informed concent
(9) Adequate organ function
Key exclusion criteria
(1) Uncontrolled infection.
(2) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
(3) Severe lung disease.
(4) Interstitial lung disease or pulmonary fibrosis.
(5) Severe liver disease.
(6) Severe renal failure, or urinary protein (more than 2+).
(7) Previous history of severe drug-induced allergy
(8) ileus, bowel obstruction
(9) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
(10) History of active double cancer.
(11) Massive pleural effusion or ascites that required drainage.
(12) Brain metastasis
(13) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(14) Not appropriate for the study at the physician's assessment.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Nakayama |
Organization
Nagoya University Gradeate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
65,turumaityou,syouwaku,nagoya city
TEL
052-744-2250
goro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Asada, Koji Torii |
Organization
Nagoya University Gradeate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
65,turumaityou,syouwaku,nagoya city
TEL
052-744-2250
Homepage URL
http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
goro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chube Clinical Oncology Group (CCOG)
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
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
| 2011 | Year | 10 | Month | 06 | 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
| 2011 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2011 | Year | 10 | Month | 05 | Day |
Last modified on
| 2016 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007697
