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
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
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
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
