UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008963 |
|---|---|
| Receipt number | R000010512 |
| Scientific Title | Phase II trial of S-1+oxaliplatin+Cetuximab as first-line treatment in patients with kras-wild type unresectable advanced colorectal cancer - KODK 9 - |
| Date of disclosure of the study information | 2012/09/25 |
| Last modified on | 2015/10/21 17:14:41 |
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Basic information
Public title
Phase II trial of S-1+oxaliplatin+Cetuximab as first-line treatment in patients with kras-wild type unresectable advanced colorectal cancer - KODK 9 -
Acronym
KODK 9
Scientific Title
Phase II trial of S-1+oxaliplatin+Cetuximab as first-line treatment in patients with kras-wild type unresectable advanced colorectal cancer - KODK 9 -
Scientific Title:Acronym
KODK 9
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify efficacy and safety of S-1+oxaliplatin+cetuximab as first-line treatment in patients with kras-wild type unresectable advanced colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression Free Survival,Adverse events,Overall Survival,Relative Dose Intensity
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
(SOX+Cmab)
L-OHP 85mg/m2 i.v.(day1)
Cmab 500mg/m2 i.v.(day1)
S-1 80mg/m2(day1-7)
to be repeated every 2 weeks
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.Histopathology confirmed colorectal cancer.
2. KRAS wild-type is confirmed.
3. Presence of at least one measurable lesion (according to the RECIST v1.1)
4.ECOG performance status of 0-1.
5.No prior chemotherapy for colorectal cancer
6.Required baseline laboratory parameters (within 14 days before registration):
WBC >= 4,000/mm3
Neu >= 2,000/ mm3
Plt >= 100,000/ mm3
Hb >= 9.0g/dl
GOT,GPT<= 100U/L
T-Bil <= 1.5mg/dl
Cre <1.2mg/dl
Ccr >= 60mL/min
7.Age: 20-80 years
8. Written informed consent
9.Be able to take oral drugs
Key exclusion criteria
1.Severe complications
2.History of severe allergy
3.Peripheral sensory
4.Chickenpox
5.Receiving flucytosine
6.Serious infusion reaction has revealed
7. A case with an acute inflammatory disorder
8. Pregnant or lactating women or women of childbearing potential, and no birth-control
9. Active other malignancies.
10. Brain metastasis
11. Atopic dermatitis
12. Not appropriate for the study at
the physician's assessment
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Hasegawa |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL
03-3353-2681
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyosi Okabayashi |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL
03-3353-2681
Homepage URL
okabayashikoji@gmail.com
Sponsor or person
Institute
Department of Surgery
Keio University School of Medicine
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
慶應義塾大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 25 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 10 | Month | 21 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 23 | Day |
Last modified on
| 2015 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010512
