UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Keiji Koda
Organization	Teikyo University Chiba Medical Center
Division name	Dept of Surgery
Address	3426-3 Anesaki, Ichihara City, 2990111 Japan
TEL	0436-62-1211
Email	k-koda@umin.ac.jp

Public contact
Name of contact person	Chihiro Kosugi, Toru Tezuka
Organization	Teikyo University Chiba Medical Center
Division name	Dept of Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2009 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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