UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004863 |
|---|---|
| Receipt number | R000005611 |
| Scientific Title | A double-blind randomized controlled trial comparing 0.75mg of Palonosetron with 1mg of Granisetron for the control of highly emetogenic chemotherapy-induced emesis. |
| Date of disclosure of the study information | 2011/01/12 |
| Last modified on | 2014/04/09 16:26:01 |
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Basic information
Public title
A double-blind randomized controlled trial comparing 0.75mg of Palonosetron with 1mg of Granisetron for the control of highly emetogenic chemotherapy-induced emesis.
Acronym
Trial of granisetron versus palonosetron for emesis induced by HEC(TRIPLE)
Scientific Title
A double-blind randomized controlled trial comparing 0.75mg of Palonosetron with 1mg of Granisetron for the control of highly emetogenic chemotherapy-induced emesis.
Scientific Title:Acronym
Trial of granisetron versus palonosetron for emesis induced by HEC(TRIPLE)
Region
| Japan |
Condition
Condition
Malignant tumor (lung cancer,gastric cancer,esophagus cancer,cervical cancer,endometrial cancer,head and neck cancer,etc)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify that superiority of 0.75mg of palonosetron to 1mg of granisetron in the prevention of chemotherapy-induced nousea and vomiting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Complete response rate of vomiting within 120hours from cisplatin administration
Key secondary outcomes
1.complete control rate of events associated with vomiting within 120hours from cisplatin administrated
2.total control rate of nausea and vomiting within 120hours from cisplatin administrated
3.time to treatment failure:TTF
4.adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
granisetron1mg+dexamethasone(d1-4)+aprepitant(d1-3)
Interventions/Control_2
palonosetron0.75mg+dexamethasone(d1-4)+aprepitant(d1-3)
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)malignant tumor patients except for hematopoietic malignancy
(2)performance status(ECOG PS) of 0-2
(3)20 years-old over at the time of giving informed consent
(4)patients who receive the chemotherapy involving cisplatin as first line
(5)dose of cisplatin is 50mg/m2 over
(6)the regimens involve the standard treatment for vomiting with dexamethasone,aprepitant and 5HT3 receptor antagonist
(7)adequate organ function as defined by;(each of the following values are examined within 8days before prior to entry)
AST 100 <=IU/L ALT <= 100IU/L
T-Bill <= 2.0 mg/dL
Ccr >= 60 mL/min
(8)all subjects must be able to provide informed,written consent prio to entry
Key exclusion criteria
(1)known prior severe hypersensitivity to 5HT3 receptor antagonist,
corticosteroids and aprepitant
(2)patients who do not have enough whole body state to the antineoplastic agents treatment
(3)known symptomatic brain metastasis
(4)patients who has a convulsive disorders that need anticonvulsants therapy
(5)patients with a symptom who has ascites or pleural effusion that need puncture
(6)patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus
etc
(7)pregnant, breastfeeding or expecting woman
(8)patients enforced radiotherapy at the bottom of diaphragm on the period between 6 days before and 6 days after of the date of first therapy
(9)patients who take a medicine regularly ,for example , 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers,antihistamine drugs, benzodiazepine,agents, etc
(10)judged by the investigator to be inappropriate for this study
Target sample size
840
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Yamamoto |
Organization
Shizuoka Cancer Center
Division name
Department of respiratory medicine
Zip code
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun,Shizuoka,411-8777,Japan
TEL
055-989-5222
nyamamoto@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Suzuki |
Organization
Japanese foundation for cancer research Cancer Institute Hospital
Division name
Department of Pharmacy
Zip code
Address
3-8-31,Ariake,Koto-ku,Tokyo 135-8550,JAPAN
TEL
03-3570-0215
Homepage URL
http://www.fuji-pvc.jp/center/triple/index.aspx
kenichi.suzuki@jfcr.or.jp
Sponsor or person
Institute
Pharma Valley Center,Shizuoka Organization for Creation Industries
Institute
Department
Personal name
Funding Source
Organization
Pharma Valley Center,Shizuoka Organization for Creation Industries
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
| 2011 | Year | 01 | Month | 12 | 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
| 2011 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 27 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 27 | Day |
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 12 | Day |
Last modified on
| 2014 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005611
