UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005216 |
|---|---|
| Receipt number | R000006197 |
| Scientific Title | Randomized phase II trial of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab with exploratory analysis to predict treatment efficacy and prognosis |
| Date of disclosure of the study information | 2011/03/08 |
| Last modified on | 2017/06/01 09:23:12 |
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Basic information
Public title
Randomized phase II trial of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab with exploratory analysis to predict treatment efficacy and prognosis
Acronym
FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer
Scientific Title
Randomized phase II trial of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab with exploratory analysis to predict treatment efficacy and prognosis
Scientific Title:Acronym
FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of FOLFIRI+BV and FOLFIRI+Pmab for metastatic colorectal cancer as second-line chemotherapy.
To conduct subset analysis and translational research to predict treatment efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Progression freer survival, response rate, safety, translational 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
FOLFIRI+panitumumab
Interventions/Control_2
FOLFIRI+bevacizumab
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 metastatic or locally advanced colorectal adenocarcinoma
2) presence of radiographically or clinically confirmed disease progression during previous first-line chemotherapy using oxaliplatin, fluoropyrimidine, bevacizumab, or progression within 3 months after the last chemotherapy
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.
7) Treatment free interval with more than 2 weeks after last radiotherapy
8) Adequate bone marrow reserve (neutrophil count>=1200/mm3, platelet count>=75000/mm3, Hemoglobin level>=8g/dl), adequate hepatic function (AST and ALT<=100IU/L, or AST,ALT<=200IU/L with liver metastases, total bilirubin<=1.5mg/dl), Adequate renal function (serum creatinine<=1.5mg/dL, fulfill at least one of the following criteria; urine dipstick 1+ or less, urine protein creatinine (UPC) 1 or less, or 24-hour urine protein 1000mg or less)
9) Expected survival>= 90 days
10) Written informed consent obtained from the patient
Key exclusion criteria
1) previous history of chemotherapy including irinotecan, cetuximab, or panitumumab
2) symptomatic brain metastasis or brain metastasis with under medication
3) intestinal obstruction
4) uncontrollable ascites or pleural effusion
5) uncontrollable diarrhea
6) having other active malignancies
7) having active infections
8) pulmonary fibrosis or interstitial pneumonia
9) serious comorbidities, such as uncontrollable diabetes mellitus, severe heart disease (NYHA>III), renal failure, and liver failure
10) History of arterial thromboembolic events such as unstable angia, myocardial infarction, brain hemorrhage, and brain infarction within 6 months.
11) having wound healing problem (excluding central venous port)
12) History of major surgery within 28 days or 14 days after colostomy.
13) Meningitis carcinomatosis or uncontrollable seizures, serious mental problem or neurologic disorders
14) continuous steroid administration
15) serious drug allergy
16) HIV infection
17) Pregnant or lactating female
18) Other serious medical conditions.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Shitara |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL
04-7133-1111
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 | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27712015
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 | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | 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 | 03 | Month | 08 | Day |
Last modified on
| 2017 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006197
