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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012832
Receipt No. R000014989
Scientific Title Panitumumab plus mFOLFOX6 therapy for colorectal cancer patients of RAS wild with potential resectable metastases in relation to early tumor shrinkage
Date of disclosure of the study information 2014/01/15
Last modified on 2016/11/16

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Basic information
Public title Panitumumab plus mFOLFOX6 therapy for colorectal cancer patients of RAS wild with potential resectable metastases in relation to early tumor shrinkage
Acronym Panitumumab plus mFOLFOX6 therapy for RAS wild
Scientific Title Panitumumab plus mFOLFOX6 therapy for colorectal cancer patients of RAS wild with potential resectable metastases in relation to early tumor shrinkage
Scientific Title:Acronym Panitumumab plus mFOLFOX6 therapy for RAS wild
Region
Japan

Condition
Condition colorectal cancer with potential resectable metastases
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate early tumor shrinkage of potentially resectable metastases of colorectal cancer with Panitumumab plus modified FOLFOX 6
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Early tumor shrinkage(at the point of 8 weeks)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)histologically confirmed advanced mCRC
ecept cancer of appendix and anal canal
(2)Operable
(3)RAS wild tye
(4)Writen informed consent
(5)Age: 20-80 years
(6)Performance status (PS) 0-1
(7)Alife expectancy greater than 12 weeks
(8)Metastases classified in Group 1 of
ESMO Consensus Guidline
(9)Adequate organ function
Key exclusion criteria (1)Pleural effision or ascites or pericardial effusion to be discharged
(2)Multiple malignacies to be treated
(3)bleeding tendency(PT-INR ;1.5)
(4)Ileus,uncontrollable peptic ulcer disease
(5)Serious complications (DM, infection, diarrhea)
(6)Serious heart disease
(7)Previous history of severe drug-induced allergy
(8)Severe neuropathy
(9)With interstitial lung disease or pulmonary fibrosis
(10)Pregnant
(11)Disqualified by attending doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuiro Kodera
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya,466-8550,Japan
TEL 052-744-2253
Email ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Goro Nakayama
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya,466-8550,Japan
TEL 052-744-2253
Homepage URL
Email goro@med.nagoya-u.ac.jp

Sponsor
Institute Chubu Clinical Oncology Group(CCOG)
Institute
Department

Funding Source
Organization none
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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 15 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate early tumor shrinkage with panitumumab plus modified FOLFOX6 in the first-line setting

Management information
Registered date
2014 Year 01 Month 12 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014989

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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