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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007072
Receipt No. R000002510
Scientific Title Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer
Date of disclosure of the study information 2012/01/16
Last modified on 2016/06/30

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Basic information
Public title Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer
Acronym Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer
Scientific Title Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer
Scientific Title:Acronym Phase II study of TS-1, CPT-11 and Bevacizumab combination chemotherapy in patients with metastatic colon cancer
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness and toxicity of Irinotecan, TS-1, Bevacizumab combination chemotherapy for advancer colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate
Key secondary outcomes Overall survival
Progression-free survival
Toxicity

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 CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks.
TS-1 80 mg/m2/day is administered orally for 4 consecutive weeks every 6 weeks.
Bevacizumab 7mg/kg is administered with 30-90 min intravenous injection on days 1, 15.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with pathologically proven colorectal cancer.
2) Patients with unrecectable metastatic colorectal cancer.
3) Patients with confirmed target lesion.
4) Patients with no prior chemotherapy.
5) Patients with no prior radiotherapy.
6) Patients of age =>20 and 75>
7) Patients with expected life for at least 3 month.
8) Performance Status:0-1(ECOG)
9) Sufficient organ functions
1:hemoglobin>=9.0g/dL
2:WBC >=3,500/mm3 and 12000/mm3>
3:neutrophils>=1,500/mm3
4:platelets>=100,000/mm3
5:total bilirubin <=1.5mg/dL
6: ALT AST<=100IU (or <=150IU if liver metastases were present)
7:serum creatinine <= 1.2mg/dL
8:creatinine clearance>=60ml/min
10) Capability of oral intake
11) Normal cardiac function confirmed by cardiac electro gram within 28 days of registration
12) Written informed consent
Key exclusion criteria 1) Patients with pathologically proven colorectal cancer.
2) Patients with unrecectable metastatic colorectal cancer.
3) Patients with confirmed target lesion.
4) Patients with no prior chemotherapy.
5) Patients with no prior radiotherapy.
6) Patients of age =>20 and 75>
7) Patients with expected life for at least 3 month.
8) Performance Status:0-1(ECOG)
9) Sufficient organ functions
1:hemoglobin>=9.0g/dL
2:WBC >=3,500/mm3 and 12000/mm3>
3:neutrophils>=1,500/mm3
4:platelets>=100,000/mm3
5:total bilirubin <=1.5mg/dL
6: ALT AST<=100IU (or <=150IU if liver metastases were present)
7:serum creatinine <= 1.2mg/dL
8:creatinine clearance>=60ml/min
10) Capability of oral intake
11) Normal cardiac function confirmed by cardiac electro gram within 28 days of registration
12) Written informed consent
1) Medical history of severe anaphylaxis or allergia to any drug
2) Patients with active synchronous or metachronous malignancy other than carcinoma in situ
3) Severe infection
4) Perforation of the digestive tract or paralyzed intestinal tract within 1 year of registration
5) Uncontrollable hypertension with medical therapy
6) Severe complication (lung fibrosis or intestinal pneumonia, heart failure, renal failure, hepatic insufficiency, uncontrolled diabetes etc)
7) Massive pleural or abdominal effusion
8) Watery diarrhea
9) Need to treatment with flucytosine or atazanavir sulfate
10) Patients with brain metastases
11) Pregnant or nursing
12) Severe mental illness
13) Systemic administration of corticosteroids
14) Patients with uric protein 2+
15) Patients with thrombosis
16) Patients with cerebral infarction, cardiac infarction or pulmonary infarction
17) Patients who underwent surgery within 4 weeks
18) Systemic administration of antiplatelet drug
19) Patients with known bleeding disorders or clotting disorder
20) Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Murata
Organization Suita Municipal Hospital
Division name Department of Surgery
Zip code
Address 2-13-20 Katayama-cho Suita city Osaka, Japan
TEL 06-6387-3311
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Murata
Organization Suita Municipal Hospital
Division name Department of Surgery
Zip code
Address 2-13-20 Katayama-cho Suita city Osaka, Japan
TEL 06-6387-3311
Homepage URL
Email kmuratajp@yahoo.co.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
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
2012 Year 01 Month 16 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
2009 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 06 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
2012 Year 01 Month 16 Day
Last modified on
2016 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002510

Research Plan
Registered date File name
2016/07/06 転移性大腸癌に対するTS-1CPT-11+Bevacizumab臨床第II相試験.zip

Research case data specifications
Registered date File name

Research case data
Registered date File name


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