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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012442
Receipt No. R000014528
Scientific Title Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6 plus bevacizumab or XELOX plus bevacizumab
Date of disclosure of the study information 2013/11/29
Last modified on 2017/12/04

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Basic information
Public title Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6 plus bevacizumab or XELOX plus bevacizumab
Acronym Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6+bevacizumab or XELOX+bevacizumab
Scientific Title Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6 plus bevacizumab or XELOX plus bevacizumab
Scientific Title:Acronym Biomarker analysis in advanced colorectal cancer patients treated with mFOLFOX6+bevacizumab or XELOX+bevacizumab
Region
Japan

Condition
Condition Advanced colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the correlation between the efficacy (PFS) and the biomarker in treated with mFOLFOX6+bevacizumab or XELOX+bevacizumab as first-line treatment of patients with advanced colorectal cancer
Basic objectives2 Others
Basic objectives -Others Correlation between biomarkers and progression free survival
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Correlation between plasma VEGF-A level and Progression free survival time in CRC patients
Key secondary outcomes 1) Correlation between plasma VEGF-A level and overall survival time in CRC patients
2) Correlation between plasma VEGF-A level and response rate to the chemotherapy in CRC patients
3) Searching predictive/prognostic biomarkers other than VEGF-A in CRC patients
4) OS, PFS, ORR and the safety of Fluorouracil+Oxaliplatin+Bevacizumab chemotherapy in CRC patients

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 mFOLFOX6 + Bevacizumab or
XELOX + Bevacizumab
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. Histopathologically confirmed colorectal adenocarcinoma which is
a) Metastatic or locally advanced unresectable CRC with no prior therapy
b) Recurrence after resection of the primary and/or metastatic lesion and not a candidate for re-resection, and;
i) with no prior therapy other than surgery
ii) with post-operative adjuvant chemotherapy in the following conditions;
1)Relapsed at 180 day or after from the last administration of FU (w/wo LV)
2)Relapsed at 366 days or after from the last administration of Oxaliplatin
3) Only use of FU (w/wo LV) and/or Oxaliplatin are permitted as post-operative adjuvant chemotherapy
2. ECOG PS of 0 or 1.
3.Have evaluable lesions;
Following lesions are considered as not evaluable; Malignant effusion, bone metastasis, pulmonary lymphangites, abdominal masses that is not measurable by reproducible imaging and cystic lesions
4. Adequate hematologic, renal, and hepatic function as defined by required baseline laboratory parameters.
a) WBC count>=3000/mm3 and <=12000mm3
b) Platelet count>=100000/mm3
c) Hemoglobin level>=9g/dl
d) Total bilirubin<=1.5mg/dl
e) AST and ALT<=100IU/L (or AST,ALT<=200IU/L with liver metastases)
f) Serum creatinine<=1.5mg/dL
g) INR<1.5
h) Urine dipstick 1+ or less
5. Expected survival>= 90 days
6. Written informed consent obtained from the patient
Key exclusion criteria 1. Brain metastasis with symptoms.
2. Massive ascites, pleural effusion or pericardial effusions that need medical treatment.
3. Active another malignancies
4. Non-healing wound (excluding central venous port)
5. Major surgical procedure within 28 days prior to enroll in this study. (Minor surgical procedure within 14 days prior to enroll in this study.)
6. Other serious concomitant disease.
a) intestinal obstruction
b) History of arterial thromboembolic events such as unstable angina, myocardial infarction, and cerebrovascular accidents within 6 months.
c) Clinically significant cardiovascular disease
d) Severe pulmonary fibrosis, interstitial pneumonia or COPD on chest XP
e) Uncontrollable hypertension
f) Uncontrollable diabetes mellitus
g) Active peptic ulcer
h) Uncontrollable diarrhea
i) Hemorrhagic Diathesis
j) HIV infection
7. Regular use of corticosteroid.
8. Peripheral neuropathy>=Grade 1 at baseline.
9. Active local or systemic infectious disease.
10. History of serious hypersensitivity.
11. Blood tests positive for HBs antigen.
12. Uncontrollable severe mental disorder.
13. Pregnant or lactating female.
14. Judged inappropriate by the investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Okamoto
Organization National Cancer Center
Division name Division of Translational Research, Exploratory Oncology Research & Clinical Trial Center
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Email wokamoto@east.ncc.go.jp

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 6-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 WJOG消化器がん参加施設

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2013 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 07 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
2013 Year 11 Month 29 Day
Last modified on
2017 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014528

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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