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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005506
Receipt No. R000006530
Scientific Title Efficacy and safety of a triple antiemetic combination with palonosetron, dexamethasone and aprepitant in patients receiving multiple-day cisplatin-containing chemotherapy.
Date of disclosure of the study information 2011/04/25
Last modified on 2014/07/04

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Basic information
Public title Efficacy and safety of a triple antiemetic combination with palonosetron, dexamethasone and aprepitant in patients receiving multiple-day cisplatin-containing chemotherapy.
Acronym Efficacy and safety of a triple antiemetic combination in patients receiving multiple-day cisplatin-containing chemotherapy.
Scientific Title Efficacy and safety of a triple antiemetic combination with palonosetron, dexamethasone and aprepitant in patients receiving multiple-day cisplatin-containing chemotherapy.
Scientific Title:Acronym Efficacy and safety of a triple antiemetic combination in patients receiving multiple-day cisplatin-containing chemotherapy.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy by complete response (no vomiting and no rescue medication) during the overall period (Days 1-9) and safety of the antiemetic therapy.
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 (no vomiting and no rescue medication) during Days 1-9.
Key secondary outcomes (1) The proportion of patients with CR in acute phase (Days 1-5) or delayed phase (Days 6-9).
(2) Incidence and severity of nausea in the overall period, acute phase or delayed phase.
(3) The proportion of patients receiving rescue medication.
(4) The proportion of patients developing adverse drug reactions.

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 0.75 mg, iv (Day 1)
dexamethasone 9.9 mg, iv (Day 1)
dexamethasone 6.6 mg, iv (Days 2-8)
aprepitant 125 mg, oral (Day 1)
aprepitant 80mg, oral (Days 2-5)
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) Patients diagnosed as germ cell tumor histologically and/or serologically.
(2) Patients scheduled to receive 5-day fractionated chemotherapy with cisplatin in hospitalization.
(3) 20 years old or older at time of registration.
(4) ECOG PS of patients is 0-2.
(5) Patients can fill a questionnaire appropriately.
(6) Patients will provide written informed consent.
Key exclusion criteria (1) Patients have primary or secondary brain and/or intestinal cancer.
(2) History of hypersensitivity to any drugs included in the protocol therapy.
(3) Patients developing vomiting or retching within 24 hours prior to beginning chemotherapy.
(4) Patients receiving antiemetic agents including benzodiazepines within 48 hours prior to beginning chemotherapy.
(5) Patients during treatment with pimozide.
(6) Patients receiving at least one drug in the following drugs : macrolide antibiotics, azole antifungal agents, barbiturates, warfarin, phenytoin, diltiazem, midazolam, tolbutamide, hormonal contraceptives, HIV protease inhibitors.
(7) Patients considered to be ineligible for this study by physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Kawakami
Organization Graduate School of Medicine and Public Health, Kyoto University
Division name Department of Pharmacoepidemiology
Zip code
Address Yoshidakonoecho, Sakyo-ku, Kyoto, Japan 606-8501
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine and Public Health, Kyoto University
Division name Department of Pharmacoepidemiology
Zip code
Address
TEL 075-753-9469
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine and Public Health, Kyoto University
Institute
Department

Funding Source
Organization Graduate School of Medicine and Public Health, Kyoto University
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
2011 Year 04 Month 25 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
2011 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 03 Month 04 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 25 Day
Last modified on
2014 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006530

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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