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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000004202
Receipt No. R000004997
Scientific Title Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen.
Date of disclosure of the study information 2010/09/05
Last modified on 2018/03/22

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Basic information
Public title Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen.
Acronym Phase II study of palonosetron, aprepitant and dexamethazone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy.
Scientific Title Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen.
Scientific Title:Acronym Phase II study of palonosetron, aprepitant and dexamethazone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy.
Region
Japan

Condition
Condition germ cell tumors
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone in patients receiving multiple-day cisplatin-based chemotherapy regimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The proportion of patients with complete response (CR : no vomiting and no use of rescue therapy ) in the overall phase ( 0-240 hour after administration of cisplatin ).
Key secondary outcomes (1)The proportion of patients with complete protection (no vomiting and no use of rescue therapy, no significant nausea) in the acute phase( 0-120 hour after administration of cisplatin ) and delayed phase ( 120-240 hour after administration of cisplatin ).
(2)Time to first vomiting.
(3)The proportion of patients with total control (no vomiting and no use of rescue therapy, no nausea)in the acute phase and delayed phase.
(4)The proportion of patients without vomiting (including patients with no use of rescue therapy) in the acute phase and delayed phase.
(5)The frequency of vomiting.
(6)No significant nausea.
(7)The proportion of patients without nausea in the acute phase and delayed phase.
(8)The degree of nausea.
(9)The proportion of patients without a rescue therapy in the acute phase and delayed phase.
(10)Time to first use of rescue therapy.

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 palonosetron 0.75mg (day 1)(iv)
aprepitant 125mg (day 1)(oral)
aprepitant 80mg (day 2-7)(oral)
dexamethasone 6.6mg (day 1-7)(iv)
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)20 Years and older
2)Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy in hospitalization.
3)Performance Status : 0-2
4)Life expectancy of at least 3 months
5)Patient can be described accurately symptom diary.
6)WBC ; 3,000/mm3 and Absolute Neutrophil Count (ANC); 1,500/mm3
Platelets ; 100,000/mm3
Aspartate aminotransferase (AST, SGOT) and Alanine aminotransferase (ALT, SGPT) < 2.5 x upper limit of normal
Bilirubin < 1.5 x upper limit of normal
Serum Creatinine < 1.5 x upper limit of normal
7)Patient will provide written informed consent and authorization to release personal health information.
Key exclusion criteria 1)Patients treated with stem cell transplantation in parallel with cisplatin chemotherapy.
2)No use of another antiemetic agent within 48 hours prior to beginning chemotherapy.
3)No use of benzodiazepine or opioids within 48 hours prior to beginning chemotherapy.
4)No use of systemic steroids within 72 hours prior to beginning chemotherapy.
5)No apply of radiotherapy within day -6 to 10.
6)No vomiting within 24 hours prior to beginning chemotherapy.
7)No known CNS metastasis.
8)No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics Clarithromycin, azole antifungal agents (Ketoconazole, Itraconazole)
9)No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Phenytoin, Carbamazepine, and barbiturates.
10)Subject with uncontrolled diabetes or a concurrent illness/condition requiring chronic systemic steroids.
11)No known hypersensitivity to any component of study regimen.
12)Patients judged inappropriate for this study by physicians.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Midori Hirai
Organization Kobe University Hospital
Division name Department of Hospital Pharmacy
Zip code
Address 7-5-2 kusunoki-cho Chuo-ku Kobe Hyogo 650-0017 JAPAN
TEL 078-382-6669
Email ioroit@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Ioroi
Organization Kobe University Hospital
Division name Department of Hospital Pharmacy
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL 078-382-6669
Homepage URL
Email chiken@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Institute
Department

Funding Source
Organization Kobe University Hospital
Organization
Division
Category of Funding Organization Other
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
2010 Year 09 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs00520-017-3967-2
Number of participants that the trial has enrolled
Results
Twenty-five patients were enrolled and evaluated for safety, and 24 patients were evaluated for efficacy. CR was achieved in 62.5% of patients (95% confidence interval [CI]?=?40.6-81.2, p?=?0.043) in the overall period. CP and TC were achieved in 62.5% (95% CI?=?40.6-81.2) and 25.0% of patients (95% CI?=?9.8-46.7), respectively, in the overall period. The primary adverse drug reaction was hiccups (48.0%). The events were expected, and none was grade 3 or 4.
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 Main results already published
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2015 Year 02 Month 28 Day
Date of closure to data entry
2015 Year 05 Month 31 Day
Date trial data considered complete
2015 Year 07 Month 01 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 14 Day
Last modified on
2018 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004997

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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