UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005884 |
|---|---|
| Receipt number | R000006949 |
| Scientific Title | Phase II Study of bi-weekly SOX+Cetuximab for EGFR positive and K-ras wild type dvanced and recurrent Colorectal Cancer |
| Date of disclosure of the study information | 2011/06/29 |
| Last modified on | 2019/07/05 10:21:52 |
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Basic information
Public title
Phase II Study of bi-weekly SOX+Cetuximab
for EGFR positive and K-ras wild type dvanced and recurrent Colorectal Cancer
Acronym
KW-SOXCet
Scientific Title
Phase II Study of bi-weekly SOX+Cetuximab
for EGFR positive and K-ras wild type dvanced and recurrent Colorectal Cancer
Scientific Title:Acronym
KW-SOXCet
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate response rate of cetuximab, oxalipatin and S-1 in non-previously treated patients with K-RAS wild-type and EGFR positive advanced colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response ratte : RR
Key secondary outcomes
Safety,Overall survival,Time to progression,Progression Free Survival
,Compliance
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
Oxaliplatin:85mg/m2/week iv, day1.15 q 4weeks
Cetuximab:day1 400, day8 250, day15 500mg/m2, day15- q 2weeks
S-1:80mg/m2, day1-14 q 4weeks
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histopathologically confirmed colorectal cancer.
2) EGFR positive, K-RAS wild-type, unresectable colorectal cancer.
3) Evaluable tumor lesions (RECIST ver.1.1).
4) ECOG Performance status (PS) of 0-1.
5) Colorectal cancer that is not amenable to curative resection and have non-previously received chemotherapy.
6) No severe organ failure: and suitable results of all laboratory test performed.
White blood cell count >= 3,000/mm3
Neutrophil count >= 1,500/mm3
platelet count >= 75,000/mm3
hemoglobin >=8.0g/dl
GOT,GPT: 100 U/L
GOT and GPT <= 100. if the patient has liver metastasis <= 200.
Total bilirubin <= 1.5mg/dL
serum creatinine <= 1.2 mg/dL
(CCr)60mL/min <=
ECG: normal
7) Age of 20<=, <=75 years.
8 ) Written informed consent will be obtained from each patient before enrollment.
9) considered to survive for more than 3 months.
10) be able to take oral drugs
Key exclusion criteria
1)Serious complications(intestinal paralysis and intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, renal failure, cardiac failure , liver failure)
2)History of serious drug hypersensitivity
3)Peripheral neuropathy
4)without helpes simplex
5)Requiring flucytosine.
6)History of serious Infusional reaction.
7)Active infection.
8)renal dysfuncsion serum creatinine <= 1.2 mg/dL
(CCr) 60mL/min <=
9)Pregnant or lactating woman
10)Active other malignancies.
11)Symptomatic brain metastasis
12)Atopic delmatitis
13)Not appropriate for the study at the physician's assessment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Anan |
Organization
Jikei Medical University School of Medicine
Division name
Gatrointestinal surgery
Zip code
1058461
Address
3-19-18, Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
anan@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Anan |
Organization
Jikei Medical University School of Medicine
Division name
Gatrointestinal surgery
Zip code
1058461
Address
3-19-18, Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
anan@jikei.ac.jp
Sponsor or person
Institute
Jikei Medical 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
Jikei Medical University School of Medicine
Address
3-19-18, Nishi-shinbashi, Minato-ku, Tokyo, Japan
Tel
03-3433-1111
rinri@jikei.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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 29 | 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
30
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
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 29 | 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 | 06 | Month | 29 | Day |
Last modified on
| 2019 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006949
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