UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000304 |
|---|---|
| Receipt number | R000000392 |
| Scientific Title | Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients |
| Date of disclosure of the study information | 2006/01/11 |
| Last modified on | 2012/10/05 20:13:42 |
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Basic information
Public title
Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients
Acronym
Randomized controlled trial of granisetron for the prophylaxis of chemotherapy-induced nausea and vomiting
Scientific Title
Randomized controlled trial of two intravenous doses of granisetron (1mg vs 3mg) for the prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients
Scientific Title:Acronym
Randomized controlled trial of granisetron for the prophylaxis of chemotherapy-induced nausea and vomiting
Region
| Japan |
Condition
Condition
breast cancer , ovarian cancer , cervical cancer , endometrial cancer , etc
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine Non-inferiority of 1mg of granisetron to 3mg of granisetron in the efficacy for chemotherapy-induced nausea and vomiting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Complete Response
Key secondary outcomes
Complete control
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Granisetron 1mg/body (drip on intravenous,day1)
Interventions/Control_2
Granisetron 3mg/body (drip on intravenous,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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)20 years-old over
(2)PS (Eastern Cooperative Oncology Group performance status scale) 0-2
(3)patients to use the neoplastic agents belong to the acute emetic High risk category <refer to the ASCO clinical practice guideline,Recommendations for the use of Antiemetics>
(4)Each of the following values are examined within 3weeks before registration for this study
1)ANC>=1,000/mm2
2)GPT(ALT) <100IU/L
3)CRE<=1.5 (CBDCA:CRE<=2.5)
(5)Written informed consent
Key exclusion criteria
(1)patients with known hypersensitivity to 5-HT3 receptor antagonist
(2)patients to use the neoplastic agents belong to the acute emetic category intermediate and High risk or to do the radiation therapy between Day2 and 7
(3)serious complications excepting malignancy (e.g. bowel obdormition, fibroid lung, cerebrovascular accident, active gastric and duodenum)
(4)can't exactly record episodes in diaries, Shoujyou-nisshi
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taisuke Hojo , Ph.D |
Organization
National Cancer Center Hospital
Division name
Pharmacy Division
Zip code
Address
5-1-1 Tsukiji,Chuuou-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahito Yonemura |
Organization
Granisetorn coordinating office
Division name
Pharmacy Division of National Cancer Center Hospital
Zip code
Address
5-1-1 Tsukiji,Chuuou-ku,Tokyo,104-0045,Japan
TEL
03-3542-2511
Homepage URL
myonemur@ncc.go.jp
Sponsor or person
Institute
Pharmacy Division of National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2006 | Year | 01 | Month | 11 | 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
| 2005 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 01 | Month | 11 | Day |
Last modified on
| 2012 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000392
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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