UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001853 |
|---|---|
| Receipt number | R000002195 |
| Scientific Title | Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab for patients with metastatic colorectal cancer: a prospective phase II study |
| Date of disclosure of the study information | 2009/04/06 |
| Last modified on | 2015/05/10 16:37:51 |
* 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
Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab for patients with metastatic colorectal cancer: a prospective phase II study
Acronym
Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab
Scientific Title
Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab for patients with metastatic colorectal cancer: a prospective phase II study
Scientific Title:Acronym
Preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX plus bevacizumab
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 preventive effect of shakuyaku-kanzo-to on neurotoxicity of FOLFOX 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
Phase II
Assessment
Primary outcomes
Neurotoxicity frequency of accumulation dose 500mg/m2 of oxaliplatin
Key secondary outcomes
Time to treatment failure
Progression-free survival
Response rate
Adverse events
Neurotoxicity incidence
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
Patients receive FOLFOX4 plus bevacizumab or modified FOLFOX6 plus bevacizumab and take shakuyaku-kanzo-to (7.5g/day) orally every day during FOLFOX plus bevacizumab treatment.
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. Histologically confirmed adenocarcinoma of the colon and rectum
2. Unresectable or recurrent colorectal cancer
3. No prior chemotherapy, immunotherapy and radiotherapy
4. Age 20<= years
5. ECOG performance status of 0,1
6. Life expectancy at least 12 weeks
7. Adequate organ function
8. Sufficient oral intake
9. Written informed consent
Key exclusion criteria
1. Active other malignancies
2. Brain metastasis
3. Massive pleural effusion or ascites
4. History of severe drug hypersensitivity
5. Uncontrollable hepertension
6. Severe complications(ileus, interstitial pneumonitis, pulmonary fibrosis, uncontrollable diabetes mellitus, heart failure)
7. History of thromboembolitic disease
8. Bleeding diathesis
9. Active peptic ulcer
10. Active infectious disease
11. Uncontrollable watery diarrhea
12. Peripheral neuropathy
13. Aldosteronism
14. Myopathy
15. Surgical procedure within 4 weeks before registration
16. Psychosis
17. Pregnant or lactating woman
18. Not appropriate for the study at the physician's assessmnt
Target sample size
40
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
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
| 2009 | Year | 04 | Month | 06 | 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 | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 06 | 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=R000002195
