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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011674
Receipt No. 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

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Basic information
Public 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 -
Acronym mFOLFOX6+Pmab NAC Study
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 -
Scientific Title:Acronym mFOLFOX6+Pmab NAC Study
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall Response Rate
Key secondary outcomes Resection rate of metastatic resion
Liver metastases R0 resection rate
Safety
relapse-free survival
Overall Survival

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 mFOLFOX6+Pmab is repeated every 14 days until meeting the withdrawal criteria.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Tsuchida
Organization Tokyo Medical University
Division name 3rd department of surgery
Zip code
Address 6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL 03-3342-6111
Email akihikot@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Katsumata
Organization Tokyo Medical University
Division name 3rd department of surgery
Zip code
Address 6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL 03-3342-6111
Homepage URL
Email k-katsu@tokyo-med.ac.jp

Sponsor
Institute 3rd department of surgery
Tokyo Medical University
Institute
Department

Funding Source
Organization Tokyo Medical University
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
Address
Tel
Email

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 東京医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 13 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 Open public recruiting
Date of protocol fixation
2013 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 04 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
2013 Year 09 Month 06 Day
Last modified on
2013 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013651

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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