UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010402 |
|---|---|
| Receipt number | R000012165 |
| Scientific Title | Phase II study of S-1 alternate-day and bevacizumab in elderly patients with advanced colorectal cancer |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2018/10/09 07:47:28 |
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Basic information
Public title
Phase II study of S-1 alternate-day and bevacizumab in elderly patients with advanced colorectal cancer
Acronym
TCTG-SGOSG joint study, Phase II study of S-1 alternate-day and bevacizumab in elderly patients with advanced colorectal cancer (J-SAVER)
Scientific Title
Phase II study of S-1 alternate-day and bevacizumab in elderly patients with advanced colorectal cancer
Scientific Title:Acronym
TCTG-SGOSG joint study, Phase II study of S-1 alternate-day and bevacizumab in elderly patients with advanced colorectal cancer (J-SAVER)
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of S-1 alternative-day and bevacizumab in elderly patients with advanced colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Adverse events
Overall survival
Response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 80 mg/m2/day (administration on Mon, Wed, Fri, and Sun)
Bevacizumab 7.5 mg/kg (every 3 weeks)
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with pathologically proven colorectal cancer
2)Patients with confirmed target lesion
3)Patients with no prior chemotherapy
4) Over 75 years old
5)Performance Status0-1(ECOG)
6)Patients with expected life for at 3 months
7)Sufficient organ functions
WBC>=3000/mm3
Neutrophils>=1500/mm3
Hemoglobin>=9.0g/dl
Platelets>=100000/mm3
AST/ALT<=100IU
Total bilirubin<=1.5mg/dl
Creatinine<=1.2mg/dl
normal ECG
8)Written informed consent
9)Capability of oral intake
Key exclusion criteria
1) Concurrent treatment with prohibited medications, including phenytoin and flucytosine
2) Administration contraindication of S-1 and bevacizumab
3) Serious infection
4) HBsAg positive
5) Active double cancer
6) Uncontrolled hypertention
7) Severe complications
8) History of radiation therapy over the pelvic cavity
9) Massive pleural or abdominal effusion
10) Patient with the diarrhea
11) Brain metastasis with symptom
12) Uric protein 2+
13) Men of the fertility hope
14) Pregnant or lactating female at any time during study
15) Systemic administration of corticosteroids
16) History of Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction
17) Patients who underwent surgery within 4 weeks
18) Systemic administration of antiplatelet drug
19) Patients with known bleeding disorders or clotting disorder
20) Severe mental illness
21) Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichinosuke Hyodo |
Organization
University of Tsukuba
Division name
Division of Gastroenterology, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba-shi, Ibaraki-ken, Japan
TEL
029-853-3218
ihyodo@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshikazu Moriwaki |
Organization
University of Tsukuba
Division name
Division of Gastroenterology, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba-shi, Ibaraki-ken, Japan
TEL
029-853-3218
Homepage URL
tmoriwak@md.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba cancer clinical trial group
Shikoku gastrointestinal oncology study group
Institute
Department
Personal name
Funding Source
Organization
Tsukuba cancer clinical trial group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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 | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 09 | Month | 21 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012165
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