UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006643 |
|---|---|
| Receipt number | 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 11:27:23 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007852
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