UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002354 |
|---|---|
| Receipt number | R000002885 |
| Scientific Title | Multicenter Phase II study of modified FOLFOX7(combination chemotherapy of infusional 5-FU/l-Leucovorin and intermittent Oxaliplatin)with bevacizumab in the first-line therapy of colorectal cancer - CRAFT trial- |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2016/05/24 20:05:34 |
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Basic information
Public title
Multicenter Phase II study of modified FOLFOX7(combination chemotherapy of infusional 5-FU/l-Leucovorin and intermittent Oxaliplatin)with bevacizumab in the first-line therapy of colorectal cancer - CRAFT trial-
Acronym
Avastin plus intermittent mFOLFOX7 therapy in advanced colorectal cancer-CRAFT trial- Multicenter Phase II study
Scientific Title
Multicenter Phase II study of modified FOLFOX7(combination chemotherapy of infusional 5-FU/l-Leucovorin and intermittent Oxaliplatin)with bevacizumab in the first-line therapy of colorectal cancer - CRAFT trial-
Scientific Title:Acronym
Avastin plus intermittent mFOLFOX7 therapy in advanced colorectal cancer-CRAFT trial- Multicenter Phase II study
Region
| Japan |
Condition
Condition
advanced colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to evaluate efficacy and
safety of intermittent mFOLFOX7 and bevacizumab regimen in the 1st line therapy of advanced 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
PFS2:PFS between PD in msLV5FU2+bevacizumab and PD after Oxaliplatin reintroduction
Response rate
Response rate2: response rate in Oxaliplatin reintroduction
Time to treatment failure
Safely
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(mFOLFOX7+bevacizumab)x8cycle followed by
(sLV5FU2+bevacizumab)x8cycle, followed by
(mFOLFOX7+bevacizumab)x8cycle is treated until progression
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Written informed consents
2, Age: 20-79 years old
3, Performance Status(ECOG): 0-1
4, Life expectancy estimated>= 3 months
5, Histlogical confirmed colorectal cancer
6, With estimative lesion
7, Untreated for advanced or recurrence colorectal cancer
(8) Sufficient organ functions
1 WBC=<4,000/mm3, Neurtophils >=2,000/mm3
2 Platelets>=100,000/mm3
3 Hemoglobin>=9.0g/dl
4 Total bilirubin=<upper limit of normal (ULN)x1.5
5 AST and ALT=<upper limit of normal (ULN)x2.5
(=<ULNx5 in case of liver metastasis)
6 Serum creatinine =<upper limit of normal (ULN)x1.5
Key exclusion criteria
1, Need to drain malignant coelomic fluid
2, Symptomatic brain metastasis
3, Multiple primary cancer within 5years
4, With suspected complication of arterial thromboembolism (ex:cerebrovascular disease)or experienced thrombosis within 1year/ twice of thrombosis
5, Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks.
6, Planning a surgery during the study.
7, Administering antithrombotic drug within 14 days.
8, Need to administrate or having anti-platelets therapy (including aspirin and NSAIDS)
9, Bleeding tendency(including hemoptysis) or coagulation disorder (INR>=1.5)
10, Uncontrolled complication of peptic ulcer.
11, Current or previous (within one year) history of GI perforation
12, Serious renal complications or having 2+ uric protein
13, Uncontrolled High blood pressure.
14, Symptomatic or symptomatic or asymptomatic but treated heart disease but treated heart disease
15, Serious drug hypersensitivity or a history of drug allergy (5FU, oxalipratin, Levofolinate calcium)
16, Experienced adverse drug reaction caused by fluoropyrimidines with suspected dihydropyrimidine dehydrogenase (DPD) deficiency
17, Uncontrolled diarrhea
18, Peripheral neuropathy(Grade 1=<)
19, Uncontrolled infection
20, Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
21, Previously treated with bevacizumab or oxaliplatin
22, Other conditions not suitable for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Koda |
Organization
Teikyo University Chiba Medical Center
Division name
Dept of Surgery
Zip code
Address
3426-3 Anesaki, Ichihara City, 2990111 Japan
TEL
0436-62-1211
k-koda@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chihiro Kosugi, Toru Tezuka |
Organization
Teikyo University Chiba Medical Center
Division name
Dept of Surgery
Zip code
Address
3426-3 Anesaki, Ichihara City
TEL
0436-62-1211
Homepage URL
tezuka@med.teikyo-u.ac.jp
Sponsor or person
Institute
Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2009 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 20 | Day |
Last modified on
| 2016 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002885
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
