UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012832
Receipt number 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 09:10:11

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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 or person

Institute

Chubu Clinical Oncology Group(CCOG)

Institute

Department

Personal name



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

Value
https://center6.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