UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012442 |
|---|---|
| Receipt number | 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 | 2023/01/10 09:47:15 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 09 | Day |
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
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014528
