Unique ID issued by UMIN | UMIN000011674 |
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Receipt number | R000013651 |
Scientific Title | Effective and safe examination of the mFOLFOX6/panitumumab combination therapy for the purpose of hepatectomizing in patients with KRAS Wild-type advanced colorectal cancer which has unresectable liver metastases - Phase II study - |
Date of disclosure of the study information | 2013/09/13 |
Last modified on | 2013/09/06 19:13:14 |
Effective and safe examination of the mFOLFOX6/panitumumab combination therapy for the purpose of hepatectomizing in patients with KRAS Wild-type advanced colorectal cancer which has unresectable liver metastases - Phase II study -
mFOLFOX6+Pmab NAC Study
Effective and safe examination of the mFOLFOX6/panitumumab combination therapy for the purpose of hepatectomizing in patients with KRAS Wild-type advanced colorectal cancer which has unresectable liver metastases - Phase II study -
mFOLFOX6+Pmab NAC Study
Japan |
colorectal cancer
Gastroenterology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the efficacy and safety of the mFOLFOX6+panitumumab combination therapy for the purpose of hepatectomizing in patients with KRAS Wild-type advanced colorectal cancer which has unresectable liver metastases.
Safety,Efficacy
Overall Response Rate
Resection rate of metastatic resion
Liver metastases R0 resection rate
Safety
relapse-free survival
Overall Survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
mFOLFOX6+Pmab is repeated every 14 days until meeting the withdrawal criteria.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1.Patients with histologically proven colorectal cancer
2.KRAS Wild-type
3.Unresectable synchronous and metachronous liver metastases
4.With measurable lesions in the liver only (no extrahepatic disease)
5.No prior chemotherapy for colorectal cancer
6.No prior radiotherapy for colorectal cancer
7.Age: 20 years old and above, 80 years old or older
8.Performance status(ECOG):0, 1
9.Life expectancy of more than 3 months
10.Sufficient organ functions
11.Written informed consent
1.Not reach hepatectomizing it even if enforcement of the preoperation chemotherapy
2.Serious drug hypersensitivity or a history of drug allergy
3.Peripheral neuropathy
4.Active concomitant malignancy
5.Severe infectious disease
6.Serious complications (renal failure or hepatic failure)
7.High blood pressure and diabetic and hypercalcemia that cannot be controlled
8.Symptomatic or asymptomatic but treated heart disease
9.Symptomatic or asymptomatic but treated heart disease
10.Histry of mental disturbances or cerebrovascular attack
11.Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer
12.Plerral effusion, peritoneal fluid and pericardial fluid
13.Symptomatic brain metastasis
14.Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity
15.Under coutinuous steroid therapy
16.History of organ transplantation
17.Traumatic gracture of unrecovery
18.Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
19.Other condition not suitable for this study
32
1st name | |
Middle name | |
Last name | Akihiko Tsuchida |
Tokyo Medical University
3rd department of surgery
6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
03-3342-6111
akihikot@tokyo-med.ac.jp
1st name | |
Middle name | |
Last name | Kenji Katsumata |
Tokyo Medical University
3rd department of surgery
6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
03-3342-6111
k-katsu@tokyo-med.ac.jp
3rd department of surgery
Tokyo Medical University
Tokyo Medical University
Self funding
NO
東京医科大学病院(東京都)
2013 | Year | 09 | Month | 13 | Day |
Unpublished
Open public recruiting
2013 | Year | 02 | Month | 05 | Day |
2013 | Year | 09 | Month | 04 | Day |
2013 | Year | 09 | Month | 06 | Day |
2013 | Year | 09 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013651
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