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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003935
Receipt No. R000004731
Scientific Title To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Date of disclosure of the study information 2010/08/01
Last modified on 2016/07/06

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Basic information
Public title To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Acronym To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Scientific Title To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Scientific Title:Acronym To evaluate the efficacy of XELOX+Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of the combination of XELOX+Bevacizumab in the patients with unresectable advanced recurrent coloreatal cancer who have first-line chemotherapy including treatment failure or refractory (without oxlplatin based regimen) as second-line chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression Free Survival
Overall survival, 1-year survival rate
Disease control rate
Response time
Safety
Overall survival from first line Second progression free survival (Progression Free Survival from first line)Case who has bevacizumab treatment in Registered patient,

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 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)Disease progression(PD)
or difficult to continue for other reason after chemotherapy with Oxaliplatin containing regimen
2)Histological confirmation of colorectal cancer.
3) Advanced or recurrent colorectal cancer that is not amenable to curative resection.
4) Age: 20 years old or more.
5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
6)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
7) Life expectancy greater than or equal to 3 months
8) Vital organ functions (listed below) are preserved within 14 days prior to entry
9) Patient of possible oral ingestion
10) Patient who doesn't have cerebral metastasis
11)Written informed consent
12) Other conditions suitable for this study
Key exclusion criteria 1) Treatment with tegafur gimestat otastat potassium Within 7 days
2)History of the serious hypersensitivity for Fluorouracil , Levofolinate calcium,platinum or bevacizumab
3) Active multiple Primary cancer within 5 years
4) History of adverse events related to DPD loss
5) Uncontrolled diarrhea
6) Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
7)Complication of cerebrovascular disease or symptoms within 1 years
8) Administering antithrombotic drug within 10 days before enrollment
9)Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS)
10)Evidence of bleeding diathesis or
coagulopathy
11)Symptom of colorectal obstruction
12)uncontrolled complication of peptic ulcer
13)Current or previous (within the last 1 year) history of GI perforation
14)Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry
15)Uncontrolled Hypertension
16)Uncontrolled Infection
17)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers
18)Man who doesn't practice birth control
19)Treatment history of Oxlplatin
20)Other conditions not suitable for this study
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mutsumi Hukunaga
Organization Sakai Municipal Hospital
Division name Surgery
Zip code
Address 1-1-1 minamiyasuityo sakai-ku sakai city Osaka
TEL 072-221-1700
Email fukunaga-m@sakai-hospital.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Ikeda Tsunekazu Mizushima
Organization Osaka University Graduate School of Medicine
Division name Department of Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871,Japan
TEL 06-6879-3251
Homepage URL
Email tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2010 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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
2010 Year 07 Month 21 Day
Last modified on
2016 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004731

Research Plan
Registered date File name
2016/07/06 治癒切除不能・進行再発大腸癌における2次治療としてのXELOX+ベバシズマブ併用療法に関する有効性の検討.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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