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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006643
Receipt No. R000007852
Scientific Title WJOG6510G : Randomized phase II study of panitumumab + irinotecan versus cetuximab + irinotecan in Patients Wild-Type KRAS Metastatic Colorectal Cancer Following Treatment with Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Date of disclosure of the study information 2011/11/01
Last modified on 2019/05/23

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Basic information
Public title WJOG6510G : Randomized phase II study of panitumumab + irinotecan versus cetuximab + irinotecan in Patients Wild-Type KRAS Metastatic Colorectal Cancer Following Treatment with Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Acronym WJOG6510G: Panitumumab+CPT-11 vs. Cetuximab+CPT-11 as 3rd-line for KRAS Wild-Type Colorectal Cancer.
Scientific Title WJOG6510G : Randomized phase II study of panitumumab + irinotecan versus cetuximab + irinotecan in Patients Wild-Type KRAS Metastatic Colorectal Cancer Following Treatment with Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
Scientific Title:Acronym WJOG6510G: Panitumumab+CPT-11 vs. Cetuximab+CPT-11 as 3rd-line 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 Panitumumab + Irinotecan versus Cetuximab + Irinotecan 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 Progression free survival
Key secondary outcomes Overall survival, response rate, disease control rate, safety,translational biomarker research

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 + Irinotecan
Interventions/Control_2 Cetuximab + Irinotecan
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) Patients with histopathologically proven unresectable advanced colorectal adenocarcinoma (including cecal cancer)
2) Patients have failed a prior regimen containing irinotecan, and a prior regimen containing oxaliplatin and fluoropyrimidine.
3) KRAS with wild-type
4) Age>=20years
5) ECOG performance status 0-2.
6) The presence of evaluable disease, as defined by the RECIST criteria v1.1.
7) Adequate hematologic, renal, hepatic and metabolic function :
neutrophil count>=1500/mm3,
platelet count>=100000/mm3,
Hemoglobin level>=8g/dL,
total bilirubin<=1.5mg/dL,
AST and ALT<=100IU/L, or AST,ALT<=200IU/L with liver metastases,
serum creatinine<=1.5mg/dL
8) Expected survival>=90 days
9) Written informed consent obtained from the patient
Key exclusion criteria 1) previous history of chemotherapy including cetuximab, or panitumumab
2) Final dose of prior CPT-11 <100mg/m2
3) having other active malignancies
4) severe complications (gastrointestinal bleeding, ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, ischemic heart disease, arrhythmia, heart failure renal failure, hepatic failure, glaucoma, uncontrolled diabetes mellitus, etc.)
5) having active infections
6) uncontrollable diarrhea
7) moderate/severe pleural effusion or ascites
8) history of severe drug hypersensitivity
9) continuous steroid administration
10) Treatment with atazanavir sulfate
11) repeated gastrointestinal bleeding
12) uncontrollable seizures, serious mental problem
13) Symptomatic brain metastasis or meningitis carcinomatosis.
14) Pregnant or female intend to be pregnant, and male intend to make pregnant.
15) Others.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Sakai
Organization Osaka University, Graduate School of Medicine.
Division name Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka. 565-0871, JAPAN
TEL 06-6879-2641
Email dsakai@cfs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
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
2011 Year 11 Month 01 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 22 Day
Date of IRB
2011 Year 09 Month 16 Day
Anticipated trial start date
2011 Year 12 Month 20 Day
Last follow-up date
2015 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 01 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007852

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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