UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011674 |
|---|---|
| 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 |
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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
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
k-katsu@tokyo-med.ac.jp
Sponsor or person
Institute
3rd department of surgery
Tokyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013651
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