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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002354
Receipt No. 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

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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
Email 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
Email tezuka@med.teikyo-u.ac.jp

Sponsor
Institute Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002885

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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