UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008110
Receipt number 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 11:55:27

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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 or person

Institute

Department of Urology, Sapporo Medical University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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