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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004863
Receipt No. 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

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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
Email 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
Email kenichi.suzuki@jfcr.or.jp

Sponsor
Institute Pharma Valley Center,Shizuoka Organization for Creation Industries
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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