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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004971
Receipt No. R000004978
Scientific Title Observational study of XELOX in combination with bevacizumab for advanced or recurrent colorectal cancer
Date of disclosure of the study information 2011/01/27
Last modified on 2015/07/28

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Basic information
Public title Observational study of XELOX in combination with bevacizumab for advanced or recurrent colorectal cancer
Acronym KPUMDS C-01 STUDY
Scientific Title Observational study of XELOX in combination with bevacizumab for advanced or recurrent colorectal cancer
Scientific Title:Acronym KPUMDS C-01 STUDY
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of XELOX/Bevacizumab as a first line chemotherapy for the patients with advanced or recurrent colorectal
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Progression-free survival
Time to treatment-failure
Liver resection rate
Liver R0 resection rate
Safety
Efficacy according to K-ras status (RR,PFS,TTF,Liver resection rate,Liver R0 resection rate,Safety)
RR according to smorking habit
PFS of bevacizumab-related hypertension with or without

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 Oxaliplatin 130mg/m2 i.v.(day1)
Bevacizumab 7.5mg/kg i.v.(day1) Capecitabine 2000mg/m2 p.o.(day1-14)
to be repeated every 3weeks
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with pathologically proven colorectal cancer (adenocarcinoma)
2)No prior treatment for advanced and recurrent colorectal cancer
3)With bevacizumab plus XELOX
4)With measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
5)Performance Status:0-1 (ECOG)
6)Written informed consent is taken
7)Required baseline laboratory parameters (within one week before registration)

1.neutrophils>=1,500/mm3
2.platelets>=100,000/mm3
3.hemoglobin>=9.0g/dL
4.T-Bil within 1.5 times of normal limit of each hospital
5.AST,ALT,ALP within 2.5 times of normal limit of each hospital(in case of hepatic metastatic patients are within 5.0 times of normal limit )
6.Cre within 1.5 times of normal limit of each hospital
8)Creatinine clearance<=50ml/min
Key exclusion criteria 1)Contraindication of bevacizumab oxaliplatin and capecitabine
2)Brain tumors or brain metastasis
3)Presence of cerebrovascular disease or symptoms less than 1 year prior to entry
4)Any surgical treatments oncluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
5)Non-healing bone fracture
6)Uncontrolled peptic ulcer
7)Uncontrolled hypertension
8)the internal organ transplant
9)Interstitial pneumonitis, pulmonary fibrosis
10)Uncontrolled Infection
11)Renal failure to be treated, 1+ or higher proteinuria within 1 weeks prior to entry
12)History of adverse events related to DPD loss
13)Daily treatment wit high-dose aspirin (>=325/day) or non-steroidal anti-inflammatory medications
14)Pregnant women, nursing mothers, possibly pregnant women
15)Perforation of gastrointestinal tract less than 1 year prior to entry
16)Clinically significant (i.e. active) cardiovascular disease (>= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 4), clinically important echocardiographic findigs, or past or current history (within the last 1 year) of myocardial infarction
17)Peripheral neuropathy of at least grade 1
18)Uncontrolled pleural and/or peritoneal effusion
19)Not appropriate for the study at the physician's assessment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eigo Otsuji
Organization Kyoto Prefectural University of Medicine

Division name Digestive Surgery
Zip code
Address 465 Kajii-cho Kawaramachi-dori Hirokoji Kamigyo-ku Kyoto Japan 602-8566
TEL 075-251-5527
Email otsuji@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayoshi Nakanishi
Organization Kyoto Prefectural University of Medicine
Division name Digestive Surgery
Zip code
Address 465 Kajii-cho Kawaramachi-dori Hirokoji Kamigyo-ku Kyoto Japan 602-8566
TEL 075-251-5527
Homepage URL
Email mnakan@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine

Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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
2011 Year 01 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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
2011 Year 01 Month 27 Day
Last modified on
2015 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004978

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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