UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011362
Receipt number R000007058
Scientific Title Phase II study of biweekly cetuximab+irinotecan therapy for unresectable colorectal cancer
Date of disclosure of the study information 2013/08/03
Last modified on 2016/10/07 15:29:29

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Basic information

Public title

Phase II study of biweekly cetuximab+irinotecan therapy for unresectable colorectal cancer

Acronym

Phase II study of biweekly cetuximab+irinotecan therapy

Scientific Title

Phase II study of biweekly cetuximab+irinotecan therapy for unresectable colorectal cancer

Scientific Title:Acronym

Phase II study of biweekly cetuximab+irinotecan therapy

Region

Japan


Condition

Condition

unresectable colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the efficacy and safety of biweekly cetuximab and irinotecan for unresectable colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

adverse event
disease control rate
disease free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

biweekly cetuximab

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

histologically provened colorectal cancer
adequate function of liver, kidney and heart
PS 0-2

Key exclusion criteria

severe dysfunction of bone marrow, liver, renal, and cardiac function;
prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; no other co-existing malignancy or malignancy within the last five years prior to enrollment ; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyoshi Maeda

Organization

Osaka City University

Division name

Department of Surgical Oncology

Zip code


Address

1-4-3Asahimachi, Abeno-ku, Osaka, Japan

TEL

06-6645-3838

Email

m1378386@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kiyoshi Maeda

Organization

Osaka City University

Division name

Department of Surgical Oncology

Zip code


Address

1-4-3Asahimachi, Abeno-ku, Osaka, Japan

TEL

06-6645-3838

Homepage URL


Email

m1378386@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka City University

Institute

Department

Personal name



Funding Source

Organization

Osaka City 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

大阪市立大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 03 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

2013 Year 06 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 19 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 08 Month 03 Day

Last modified on

2016 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007058


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name