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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004331 |
Receipt No. | 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 |
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 |
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Condition | ||||||
Condition | Patients with liver-only metastases from colorectal cancer | |||||
Classification by specialty |
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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 |
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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. |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 32 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Kyushu Study group of Clinical Cancer |
Institute | |
Department |
Funding Source | |
Organization | Clinical Research Support Center Kyushu |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
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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 | |||||||
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URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005188 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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