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 |
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer(KSCC1002)
Japan |
Patients with liver-only metastases from colorectal cancer
Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
Safety and efficacy of preoperative chemotherapy with SOX+Cetuximab in patients with liver-only metastases(H2,H3), KRAS-WT from colorectal cancer
Safety,Efficacy
Pragmatic
Phase II
Liver resection rate
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
32
1st name | |
Middle name | |
Last name | Hideo Baba |
Graduate School of Medical Sciences, Kumamoto University
Dept. of Gastroenterological Surgery
1-1-1 Honjo, Kumamoto, 860-8556, Japan.
092-631-2920
kscc2@cres-kyushu.or.jp
1st name | |
Middle name | |
Last name | KSCC |
Clinical Research Support Center Kyushu
KSCC
3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
092-631-2920
kscc2@cres-kyushu.or.jp
Kyushu Study group of Clinical Cancer
Clinical Research Support Center Kyushu
Non profit foundation
NO
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)
2010 | Year | 10 | Month | 06 | Day |
Unpublished
Completed
2010 | Year | 09 | Month | 27 | Day |
2010 | Year | 10 | Month | 01 | Day |
2010 | Year | 10 | Month | 06 | Day |
2017 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005188