UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007072 |
|---|---|
| Receipt number | 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 15:25:21 |
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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
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
kmuratajp@yahoo.co.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
