UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003673 |
|---|---|
| Receipt number | R000004352 |
| Scientific Title | FOLFOX plus bevacizumab alternated with sLV5FU2 plus bevacizumab as first-line chemotherapy for patients with metastatic colorectal cancer: a feasibility study |
| Date of disclosure of the study information | 2010/05/31 |
| Last modified on | 2015/05/10 16:34:16 |
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Basic information
Public title
FOLFOX plus bevacizumab alternated with sLV5FU2 plus bevacizumab as first-line chemotherapy for patients with metastatic colorectal cancer: a feasibility study
Acronym
FOLFOX and bevacizumab alternated with sLV5FU2 and bevacizumab for patients with metastatic colorectal cancer
Scientific Title
FOLFOX plus bevacizumab alternated with sLV5FU2 plus bevacizumab as first-line chemotherapy for patients with metastatic colorectal cancer: a feasibility study
Scientific Title:Acronym
FOLFOX and bevacizumab alternated with sLV5FU2 and bevacizumab for patients with metastatic colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of an alternating regimen of FOLFOX plus bevacizumab with sLV5FU2 plus bevacizumab for patients with metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Response rate
Safety
Key secondary outcomes
Progression-free survival
Overall survival
Time to treatment failure
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
Treatment consisted of modified mFOLFOX6 plus bevacizumab alternated biweekly with 5-FU/LV (simplified LV5FU2) plus bevacizumab. Treatment was administered until tumor progression, unacceptable toxicity or patient refusal.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed adenocarcinoma of the colon and rectum
2. Unresectable or recurrent colorectal cancer
3. No prior chemotherapy
4. Previous adjuvant therapy of fluoropyrimidines is permitted if completed at least 6 months before registration.
5. ECOG performance status of 0,1
6. Life expectancy of longer than 3 months
7. Adequate organ function
8. Written informed consent
Key exclusion criteria
1. Brain metastasis
2. Massive pleural effusion or ascites
3. Active other malignancies
4. Nonhealing wound
5. Surgical procedure within 28 days before registration
6. Severe complications(bowel obstruction, symptomatic cardiovascular disease, interstitial pneumonitis, pulmonary fibrosis, uncontrollable hepertension, uncontrollable diabetes mellitus, active peptic ulcer, bleeding diathesis)
7. History of thromboembolitic disease
8. Uncontrollable diarrhea
9. Administration of corticosteroids
10. Administration of anticoagulants
11. Peripheral neuropathy
12. Active infectious disease
13. History of severe drug hypersensitivity
14. Psychosis
15. Pregnant or breast-feeding women
16. Men of wishing fertility
17. Not appropriate for the study at the physician's assessmnt
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayumu Hosokawa |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address
2630 Sugitani, Toyama, 930-0194, Japan
TEL
076-434-7301
ayhosoka@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumu Hosokawa |
Organization
University of Toyama
Division name
Department of Gastroenterology and Hematology, Faculty of Medicine
Zip code
Address
2630 Sugitani, Toyama, 930-0194, Japan
TEL
076-434-7301
Homepage URL
ayhosoka@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 05 | Month | 29 | Day |
Last modified on
| 2015 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004352
