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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000003934
Receipt No. R000004730
Scientific Title To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy -PhaseI/II Study
Date of disclosure of the study information 2010/08/01
Last modified on 2017/06/24

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Basic information
Public title To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy -PhaseI/II Study
Acronym To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy- PhaseI/II Study
Scientific Title To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy -PhaseI/II Study
Scientific Title:Acronym To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy- PhaseI/II Study
Region
Japan

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

Objectives
Narrative objectives1 To decide Recommended dose of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have oxlplatin based first-line chemotherapy including treatment failure or refractory, and To evaluate the safety and efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I part: To decide Recommended dose
Phase II part: Progression Free Survival
Key secondary outcomes Response rate,Disease control rate,safety,Overall survival, 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 XELIRI+ 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 are preserved within 14 days prior to entry
Patients with UGT1A1 genotype
It doesn't have the homo and it has heterozygote of *6,*28.
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 history of irinotecan
2)History of the serious hypersensitivity for Fluorouracil or bevacizumab
3) Treatment with tegafur gimestat otastat potassium Within 7 days
4) Active multiple Primary cancer within 5 years
5)History of adverse events related to DPD loss
6) Uncontrolled diarrhea
7)Any surgical treatments oncluding skin-open biopsy,trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week
8)Complication of cerebrovascular disease or symptoms within 1 years
9)Need tobadministrate or having anti-plateles therapy(including Methotrexate aspirin and NSAIDS)
10)Evidence of bleeding diathesis or
coagulopathy
11)History of thrombosis and embolism,interstitial pneumonitis,pulmonary fibrosis or high-grade pulmonary emphysema
12)Blood transfusion,administration products support or Administering antithrombotic drug within 14 days before enrollment
13)Pleural effusion,ascites,or pericardial effusion requiring drainage
14)Symptom of colorectal obstruction
15)Freash gastrointestinal bleeding,intestinal paralysis or obstruction,uncontrolled complication of peptic ulcer
16) Current or previous (within the last 1 year) history of GI perforation
17)Renal failure to be treated,2+ or higher proteinuria within 2 weeks prior to entry
(18)Uncontrolled Hypertension and diabetes mellitus
(19)Uncontrolled Infection
20)Symptomatic brain metastasis
21)History of central nervous /cerebrovascular accident,uncontrolled mental disturbances
22)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers
23)Receiving Atazanavir Sulfate
24)Paralytic bowel obstruction
25) Other conditions not suitable for this study
Target sample size 51

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

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 2-15 yamadaoka Suita City Osaka
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 大阪大学消化器外科関連施設

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/28510802
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
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
2017 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004730

Research Plan
Registered date File name
2016/07/06 XELIRI+ベバシズマブ併用療法に関する安全性・有効性の検討-PhaseⅠⅡ Study.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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