UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000406 |
|---|---|
| Receipt number | R000000494 |
| Scientific Title | Clinical effects of azasetoron / dexamethasone combination-therapy on the prevention of nausea and vomiting caused by chemotherapy treatment for colon cancer patients - Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy - |
| Date of disclosure of the study information | 2006/04/17 |
| Last modified on | 2006/04/14 17:46:16 |
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Basic information
Public title
Clinical effects of azasetoron / dexamethasone combination-therapy on the prevention of nausea and vomiting caused by chemotherapy treatment for colon cancer patients
- Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy -
Acronym
Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy
Scientific Title
Clinical effects of azasetoron / dexamethasone combination-therapy on the prevention of nausea and vomiting caused by chemotherapy treatment for colon cancer patients
- Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy -
Scientific Title:Acronym
Comparative cross-over trial between azasetoron single-therapy and azasetoron/dexamethasone combination-therapy
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare antiemetic prophylactic effects and safety through the randomized cross-over trial between azasetoron single-therapy and azasetron/dexamethasone combination-therapy for colon cancer patients treated with chemotherapeutic agents such as Irinotecan, Oxaliplatin, Levofolinate and 5-FU
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
inhibition rate of vomiting events
Key secondary outcomes
vomiting frequency, score of nausea, patient's feelings (anti-emesis, appetite)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
drip-infusion of azasetoron (10mg/body) before the administration of anti-cancer agents (day1)
Interventions/Control_2
drip-infusion of azasetoron (10mg/body) and dexamethason (8mg/body) before the administration of anti-cancer agents (day1)
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
Colon cancer patients to be administered with chemotherapeutic agents such as Irinotecan, Oxaliplatin, Levofolinate or 5-FU (underlying disease: colon cancer)
Patients who have the abilities to agree with this study by themselves, or whose acceptance to this study can be obtained from their proxies in writing
Key exclusion criteria
Patients to receive surgical treatment or irradiation treatment during the term of this study
Patients who develop complications of severe cardiovascular disease, hemodyscrasia, renal disease or hepatic disease.
Pregnant or lactating women
Patients with a history of hypersensitivity to any of the drugs used in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Ichikawa |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-Ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
TEL
045-787-2650
Homepage URL
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
| 2006 | Year | 04 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2006 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 04 | Month | 14 | Day |
Last modified on
| 2006 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000494
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| Registered date | File name |
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