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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010319
Receipt No. R000012078
Scientific Title Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy
Date of disclosure of the study information 2013/03/26
Last modified on 2016/11/24

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Basic information
Public title Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy
Acronym JACCRO CC-07 study
Scientific Title Phase II study of TS-1+Irinotecan+Bevacizumab as second-line treatment in patients with metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy
Scientific Title:Acronym JACCRO CC-07 study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of TS-1+irinotecan+bevacizumab as second-line treatment in metastatic colorectal cancer refractory to fluonated pyrimidine, oxaliplatin, and cetuximab therapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 6-Month Progression Free Survival Rate
Key secondary outcomes Overall Survival
Progression Free Survival
Response Rate
Safety

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 TS-1+Irinotecan+Bevacizumab therapy
Bevacizumab 7.5mg/m2/tri-weekly
Irinotecan 150mg/m2/tri-weekly
TS-1 80-120mg/day, for 14 days followed by 1 week rest
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)Patients with histologically proven colorectal cancer
(2)Metastatic colorectal cancer refractory to fluoronated pyrimidine, oxaliplatin, and cetuximab therapy as first-line
(3)Presence of evaluable lesion
(4)ECOG Performance Status 0-1
(5)Age equal more 20 years old
(6)Life expectancy of more than 3 months
(7)Oral food intake possible
(8)Patiens have enough organ function for study treatment within 14 days before enrollment
WBC>=3,000/mm3, <12,000/mm3
Neu>=1,500/mm3
PLT>=10.0x104/mm3
Hb>=9.0g./dL
Total Bilirubin <= 1.5mg/dL
AST<=100 IU/L
ALT<=100 IU/L
Creatinine <=1.2mg/dL
Creatinine clearance >=50mL/min
Proteinuria<=2+
PT-INR <=1.5
(9)Written informed consent
Key exclusion criteria (1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval
(2)Symptomatic brain metastases
(3)Infectious disease
(4)Interstitial lung disease or pulmonary fibrosis
(5)Comorbidity or history of heart failure
(6)History of thromboembolic events
(7)History of hemoptysis
(8)Sensory alteration or paresthesia interfering with function
(9)Large quantity of pleural, abdominal or cardiac effusion
(10)Severe comorbidity (renal failure, liver failure, hypertension, etc)
(11)Prior radiotherapy for primary and metastases tumors
(12)Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breast feeding. Women with a positive pregnancy test
(13)History of severe allergy
(14)Surgical procedure or such as skin-open biopy, trauma surgery, or other more intensive surgeries within 4 weeks
(15)Systemic administration of antiplatelet drug or NSAIDs
(16)Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy
(17)Uncontrolled peptic ulcer
(18)History of gastrointestinal perforation within 1 year
(19)Untreated traumatic bone fracture
(20)Require treatment of renal dysfunction
(21)Doubting dihydropyrimidine dehydrogenase deficit
(22) Uncontrolled diarrhea
(23)History of organ recipient
(24)Administration of atazanavir sulfate
(25Administration of flucytosine
(26)Jaundice
(27) Ileus or bowel obstruction
(28)Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Shimada
Organization Showa University Koto Toyosu Hospital
Division name Department of Internal Medicine
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL 03-6204-6000
Email shimakenken60@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fujii
Organization Japan Clinical Cancer Research Organization
Division name Office
Zip code
Address 7F, 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email cc07.dc@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2013 Year 03 Month 26 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 No longer recruiting
Date of protocol fixation
2013 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 06 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 03 Month 26 Day
Last modified on
2016 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012078

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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