UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004331 |
|---|---|
| Receipt number | R000005188 |
| Scientific Title | Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002) |
| Date of disclosure of the study information | 2010/10/06 |
| Last modified on | 2017/04/30 18:27:46 |
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Basic information
Public title
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Acronym
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Scientific Title
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Scientific Title:Acronym
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Region
| Japan |
Condition
Condition
Patients with liver-only metastases from colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Liver resection rate
Key secondary outcomes
Liver resection rate in patients with H2 metastases
Liver resection rate in patients with H3 metastases
Progression Free Survival
Overall Survival
Response rate
Safety
R0 resection rate
Response rate in liver metastases
Pathological response rate
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
L-OHP 130mg/m2 i.v. (day1)
Cmab 250mg/m2 i.v.
(only the first time Cmab 400mg/m2)
S-1 80mg/m2 (day1-14)
to be repeated every 3 weeks for 4 cycles.
Surgery was planned after SOX+Cetuximab therapy.
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.Written informed consent
2.Appropriate for the study at the physician's assessment
3.Histopathology confirmed colorectal cancer. 4.KRAS wild-type.
5.With measurable lesions in the liver only.
6.degree of liver metastases: H2, H3
7.No prior therapy
8.ECOG performance status of 0-1.
9.Aged 20<= years.
10.considered to survive for more than 3 months.
11Required baseline laboratory parameters (within 14 days before registration):
WBC >= 3000 ,<12000/mm3
Neu >= 1,500/ mm3
Plt >= 100,000/ mm3
Hb >= 9.0g/dl
T-Bil <= 2.0mg/dl
AST,ALT<= 200U/L
Cre <1.5mg/dl
Ccr >= 50mL/min
12.be able to take oral drugs
Key exclusion criteria
1.Prior liver or pulmonary resection.
2.Administering antithrombotic drug within 7 days.
3.History of serious drug hypersensitivity or a history of drug allergy
4.Peripheral neuropathy
5.Active other malignancies.
6.Active infection.
7.Serious complications (renal failure or hepatic failure)
8.High blood pressure and diabetic and hypercalcemia that cannot be controlled
9.symptomatic or asymptomatic but treated heart disease
10.interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema
11.histry of mental disturbances, central nervous system disorder or cerebrovascular attack
12.Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer
13.Pleural effusion peritoneal fluid and pericardial fluid
14.Symptomatic brain metastasis
15.Watery stools or diarrhea
16.under continuous steroid therapy
17.Requiring flucytosine, phenytoin, Warfarin Potassium.
18.Infection with hepatitis B or C virus
19.Pregnant or lactating woman
20.No birth-control
21.Not appropriate for the study at the physician's assessment
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Baba |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Dept. of Gastroenterological Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto, 860-8556, Japan.
TEL
092-631-2920
kscc2@cres-kyushu.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KSCC |
Organization
Clinical Research Support Center Kyushu
Division name
KSCC
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL
092-631-2920
Homepage URL
kscc2@cres-kyushu.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
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
九州大学病院（福岡県）、国立病院機構九州がんセンター（福岡県）、製鉄記念八幡病院（福岡県）、社会保険田川病院（福岡県）、福岡市民病院（福岡県）、福岡大学病院（福岡県）、長崎大学病院(腫瘍外科)（長崎県）、熊本大学病院（熊本県）、済生会熊本病院（熊本県）、熊本中央病院（熊本県）、健康保険人吉総合病院（熊本県）、荒尾市民病院（熊本県）、熊本地域医療センター（熊本県）、大分大学病院（大分県）、大分赤十字病院（大分県）、国立病院機構大分医療センター（大分県）、国立病院機構別府医療センター（大分県）、国立病院機構都城病院（宮崎県）、鹿児島共済会南風病院（鹿児島県）、慈愛会今村病院（鹿児島県）、中頭病院（沖縄県）、佐世保市立総合病院（長崎県）、広島赤十字・原爆病院（広島県）、国立病院機構福岡東医療センター（福岡県）、熊本市立熊本市民病院（熊本県）、済生会福岡総合病院（福岡県）、松山赤十字病院（愛媛県）、国立病院機構南九州病院（鹿児島県）、福岡大学筑紫病院（福岡県）、公立八女総合病院（福岡県）、今給黎総合病院（鹿児島県）、久留米大学医療センター（福岡県）、天草地域医療センター（福岡県）、久留米大学病院（福岡県）、国立病院機構九州医療センター（福岡県）、済生会八幡総合病院（福岡県）、鹿児島大学（鹿児島県）、大分県立病院（大分県）、高野会高野病院（熊本県）、宗像医師会病院（福岡県）、中津市立中津市民病院（大分県）、公立学校共済組合九州中央病院（福岡県）、社会保険仲原病院（福岡県）、宮崎県立延岡病院（宮崎県）、鹿児島県立薩南病院（鹿児島県）、高知医療センター（高知県）、神戸市立医療センター中央市民病院（兵庫県）、国立病院機構再春荘病院（熊本県）、長崎大学病院（移植・腫瘍外科）（長崎県）、九州大学病院別府病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2010 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2017 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005188
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
