UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006899
Receipt number R000008143
Scientific Title Randomized phase II study of biweekly cetuximab versus panitumumab in patients not combination of irinotecan wild-type KRAS metastatic colorectal cancer following treatment with fluoropyrimidine and oxaliplatin chemotherapy
Date of disclosure of the study information 2011/12/19
Last modified on 2014/06/17 14:14:02

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Basic information

Public title

Randomized phase II study of biweekly cetuximab versus panitumumab in patients not combination of irinotecan wild-type KRAS metastatic colorectal cancer following treatment with fluoropyrimidine and oxaliplatin chemotherapy

Acronym

Phase II study of biweekly cetuximab vs. panitumumab for KRAS wild-type colorectal cancer.

Scientific Title

Randomized phase II study of biweekly cetuximab versus panitumumab in patients not combination of irinotecan wild-type KRAS metastatic colorectal cancer following treatment with fluoropyrimidine and oxaliplatin chemotherapy

Scientific Title:Acronym

Phase II study of biweekly cetuximab vs. panitumumab for KRAS wild-type colorectal cancer.

Region

Japan


Condition

Condition

advanced colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of biweekly cetuximab versus panitumumab for chemorefractory KRAS wild-type metastatic colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

overall survival

Key secondary outcomes

response rate,time to treatment failureprogression free survival,safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

panitumumab

Interventions/Control_2

cetuximab

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) Age>=20years
2) Patients with histopathologically proven unresectable advanced colorectal adenocarcinoma (including cecal cancer)
3) Patients have failed a prior regimen containing oxaliplatin and fluoropyrimidine.
4) difficulty in combination of CPT-11by physician decision
5) ECOG performance status 0-2.
6) KRAS with wild-type
7) at least 2 weeks must have elapsed since any prior chemotherapy
8) previous history of chemotherapy including cetuximab, or panitumumab
9)Adequate hematologic, renal, hepatic and metabolic function :
white blood cell>=2000/mm3
neutrophil count>=1200/mm3,
hemoglobin level>=8g/dL,
platelet count>=75000/mm3,
total bilirubin<=3.0mg/dL,
AST and ALT<=200IU/L,
serum creatinine<=1.5mg/dL
10) Written informed consent obtained from the patient

Key exclusion criteria

1)having other active malignancies
2) severe complications (uncontrolled diabetes mellitus, interstitial lung disease, pulmonary fibrosis, heart failure ,renal failure, hepatic failure, etc.)
3) having active infections
4) history of severe drug hypersensitivity
5) uncontrollable serious mental problem
7) pregnant or female intend to be pregnant, and male intend to make pregnant.
8) Others

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hyodo Ichinosuke

Organization

University of Tsukuba

Division name

Department of Gastroenterology

Zip code


Address

1-1-1 Amakubo Tsukuba city

TEL

029-853-3109

Email

koichit@iris.eonet.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Taira

Organization

Machida Gastrointestinal Hospital

Division name

Department of Clinical Oncology

Zip code


Address

1-1-5 Sanou Nishinari-ku Osaka city

TEL

0666491251

Homepage URL

http://www.tctg.or.jp/index.php

Email

koichit@iris.eonet.ne.jp


Sponsor or person

Institute

Tsukuba Center Clinical Trial Group(TCTG)

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

2011 Year 12 Month 19 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

Completed

Date of protocol fixation

2011 Year 10 Month 26 Day

Date of IRB


Anticipated trial start date

2011 Year 12 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



Management information

Registered date

2011 Year 12 Month 17 Day

Last modified on

2014 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name