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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007194
Receipt No. R000008240
Scientific Title Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bevacizumab for patients with metastatic colorectal cancer(AJUST study)
Date of disclosure of the study information 2012/02/01
Last modified on 2018/09/20

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Basic information
Public title Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bevacizumab for patients with metastatic colorectal cancer(AJUST study)
Acronym Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bmab (AJUST study)
Scientific Title Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bevacizumab for patients with metastatic colorectal cancer(AJUST study)
Scientific Title:Acronym Phase II study of 5-FU dose-adjusted mFOLFOX7 plus Bmab (AJUST study)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluated the efficacy and toxicity of 5-FU dose-adjusted mFOLFOX7 plus Bmab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes 1)Examination of 5-FU concentration in plasma
2)Relative dose intensity of oxaliplatin
3)Disease control rate
4)Time to treatment failure
5)Progression free survival
6)Overall survival
7)Resection rate
8)Adverse event

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 L-OHP 85mg/m^2 day1
Infusional 5-FU 2400mg/m^2 46hours
l-LV 200mg/m^2 day1
Bmab 5mg/kg day1
every 2 weeks

At first cycle, 5-FU concentrations are monitored. After second cycle, 5-FU are administered by the adjusted dose to mFOLFOX7+Bmab.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically confirmed colorectal cancer.
2)No prior chemotherapy for metastatic disease.(Recurrence after 24 weeks of adjuvant therapy is registered)
3)With central venous infusion and infusion pump.
4)Measurable lesion based on RECIST
ver1.1.
5)PS(ECOG) 0-1.
6)Age of 20 years or older.
7)A life expectancy of more than 12 weeks.
8)No severe organ failure: and suitable results of all laboratory test performed within 14 days before enrollment.
---WBC >= 3,000/mm^3, <= 12,000/mm^3
---Neutrophil count >= 1,000/mm^3
---Plt >= 100,000/mm^3
---AST(GOT) and ALT(GPT) <= ULN x 2.5 (the patient has liver metastasis: <= ULN x 5)
---T-Bil <= ULN x 1.5
---Cr <= ULN x 1.5
---PT-INR <= 1.5
9) Written informed consent will be obtained from each patient before enrollment.
Key exclusion criteria 1)Blood transfusion or administration of blood products or hemopoietic factors within 7 days before enrollment.
2)A history of serious drug hypersensitivity.
3)Serious sensory abnormality or dysesthesia with associated dysfunction.
4)Surgery, biopsy specimen with section or sutures within the past 2 weeks.
5)Serious heart disease.
6)Bleeding, bleeding tendency, coagulopathy, coagulation factor abnormality
7)History of GI perforation within the past one year.
8)Metachronous double cancer within the past 5 years
9)Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure )
10)Uncontrolled effusion(peritoneal , pleural, cardiac effusion)
11)Brain metastasis
12)With infection or febrile patients.
13)Serious diarrhea.
14)Women who are pregnant, lactating, or wish to become pregnant.
15)Other conditions not suitable for this study.
Target sample size 45

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi
TEL 0561-63-0386
Email hmishima@aichi-med-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yumi Miyashita
Organization Epidemiological and Clinical research Information Network (ECRIN)
Division name ECRIN Data Center
Zip code
Address 1-7-9 Hanenishi, Okazaki, Aichi, JAPAN
TEL 0564-64-7330
Homepage URL
Email miya@ecrin.or.jp

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

Funding Source
Organization NPO 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
2012 Year 02 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
Pharmacokinetic dose adjustment of 5-FU in modified FOLFOX7 plus bevacizumab for metastatic colorectal cancer in Japanese patients: a-JUST phase II clinical trial.

Denda T, Kanda M, Morita Y, Kim HM, Kashiwada T, Matsuda C, Fujieda S, Nakata K, Murotani K, Oba K, Sakamoto J, Mishima H.

Cancer Chemother Pharmacol. 2016 Nov 2. [Epub ahead of print]

RESULTS: 

The median initial area under the concentration-time curve for FU was 23 mg h/L. Twenty-nine patients (60%) achieved the target concentration at the first cycle, and all 48 achieved it within the fourth cycle. The overall frequency of grade 3/4 adverse effects was 38%, with no significant difference between patients who did and not require dose adjustments. The overall response rate was 48% (95% confidence intervals = 34-62%). The median progression-free and overall survival rates were 11.3 and 24.1 months, respectively.


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 11 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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
2012 Year 02 Month 01 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008240

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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