UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017397
Receipt number R000020183
Scientific Title Hepatic Resection for Colorectal Liver Metastases following Panitumumab(Vectibix) with Chemotherapy Cohort study
Date of disclosure of the study information 2015/05/02
Last modified on 2015/12/04 17:05:52

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Basic information

Public title

Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study

Acronym

Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study

Scientific Title

Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study

Scientific Title:Acronym

Hepatic Resection for Colorectal Liver Metastases following
Panitumumab(Vectibix) with Chemotherapy Cohort study

Region

Japan


Condition

Condition

Unresectable colorectalcancer with hepatic metastases

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim is to evaluate the complete hepatic resection rate of panitumumab as the first line chemotherapy for unresectable colorectal cancer with hepatic metastasis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase I


Assessment

Primary outcomes

Complete hepatic resection rate

Key secondary outcomes

Hepatic resection rate, response rate, complications after hepatic resection, adverse event


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. The cases histologically diagnosed as colorectal cancer
2. The cases with evaluative resectable hepatic metastatic lesions ,synchronously or metachronously
3. Unresectable hepatic metastases mean anatomic difficulty and so on.
4. The cases with possibility of hepatic resection after panitumumab chemotherapy
5. The age is 20 years old or older.
6. Performance status is 0-2 cases
7. A major organ function is maintained by a laboratory study within 14 days before registration.
8. An agreement is obtained in a document from the patients after informed consent.

Key exclusion criteria

1. The cases with serious drug hyper reaction against panitumumab, fluorouracil folinic acid, oxaliplatin, irinotecan
2. The cases with serious hypersensitivity having functional disorder or sensory disturbance
3. The cases with bone marrow suppression or its history, systemic infection, interstitial pneumonia, diarrhea, ileus, a lot of ascites or hydrothorax, icterus
4. The cases with interstitial pneumonia or its history
5. The cases with serious complications
- Poor control diabetes mellitus
- Heart failure beyond NYHA3
- Renal failure
- Liver failure
6. The cases with mutative or unjudged type about KRAS status
7. The cases without a history of chemotherapy
8. Pregnant or lactating women
9. The cases judged to be unsuitable for registration

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akinobu Taketomi

Organization

Hokkaido University Graduate school of medicine

Division name

Gastroenterological Surgery1

Zip code


Address

North15 West7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5927

Email

taketomi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norihiko Takahashi

Organization

Hokkaido University Hospital

Division name

Gastroenterology1

Zip code


Address

North15 West7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5927

Homepage URL


Email

noripiko@med.hokudai.ac.jp


Sponsor or person

Institute

Gastroenterological Surgery1, Hokkaido University Graduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University Hospital

Organization

Division

Category of Funding Organization

Other

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

2015 Year 05 Month 02 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

Terminated

Date of protocol fixation

2012 Year 06 Month 13 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation of complete hepatic resection rate


Management information

Registered date

2015 Year 05 Month 02 Day

Last modified on

2015 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name