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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008110
Receipt No. R000009544
Scientific Title Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE)
Date of disclosure of the study information 2012/06/05
Last modified on 2015/12/05

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Basic information
Public title Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE)
Acronym Antiemetic therapy in germ cell tumor
Scientific Title Aprepitant, Palonosetron and Dexamethasone Antiemetic Therapy Evaluation trial in germ cell tumor (APDATE)
Scientific Title:Acronym Antiemetic therapy in germ cell tumor
Region
Japan

Condition
Condition Germ cell tumor
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Complete response
Key secondary outcomes Conplete control (no emetic episodes, no rescue medication use and no more than mild nausea), adverse events

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 Aprepitant, palonosetron and dexamethasone
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
Key inclusion criteria 1. Germ cell tumor
2. Receiving BLM/ETP/CDDP chemotherapy
3. No history of systemic chemotherapy
4. Sufficient organ functions
5. Ability of oral intake
6. ECOG PS 0-2
7. Informed consent
Key exclusion criteria 1. Uncontrollable complications
2. Brain metastasis
3. Active convulsive disease
4. Plural effusion or ascites requiring puncture
5. Obstruction of the gastric outlet or ileus
6. Vomiting or severe nausea before the chemotherapy
7. Anaphylaxis against 5-HT3 receptor inhibitors, aprepitant or dexamethasone
8. Disapproval of contraception
9. History og aprepitant or palonostron
10. Participation of other clinical trials of antiemetics
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumimasa Fukuta
Organization Sapporo Medical University School of Medicine
Division name Department of Urology
Zip code
Address South 1 West 16, Chuo-ku, Sapporo, Japan
TEL 81-11-611-2111
Email ffukuta@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumimasa Fukuta
Organization Sapporo Medical University School of Medicine
Division name Department of Urology
Zip code
Address South 1 West 16, Chuo-ku, Sapporo, Japan
TEL 81-11-611-2111
Homepage URL
Email uroikai@sapmed.ac.jp

Sponsor
Institute Department of Urology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Sapporo Medical University School of Medicine
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 札幌医科大学附属病院(北海道)、旭川赤十字病院(北海道)、帯広協会病院(北海道)、砂川市立病院(北海道)、NTT東日本札幌病院(北海道)、王子総合病院(北海道)、函館五稜郭病院(北海道)、製鉄記念室蘭病院(北海道)

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 05 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 Open public recruiting
Date of protocol fixation
2012 Year 04 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 05 Day
Last modified on
2015 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009544

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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