UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010319 |
|---|---|
| Receipt number | 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 15:00:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
cc07.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012078
