UMIN-CTR Clinical Trial

Public title

Aprepitant for nausea, vomiting with the TC therapy of the gynecology cancer patient or the DC therapy, fosaprepitant, granisetron, protective efficacy of the dexamethasone combination therapy.

Acronym

TC, aprepitant for nausea, vomiting with the DC therapy, protective efficacy of fosaprepitant.

Scientific Title

Aprepitant for nausea, vomiting with the TC therapy of the gynecology cancer patient or the DC therapy, fosaprepitant, granisetron, protective efficacy of the dexamethasone combination therapy.

Scientific Title:Acronym

TC, aprepitant for nausea, vomiting with the DC therapy, protective efficacy of fosaprepitant.

Region

Japan

Condition

uterine cancer, ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To examine the efficacy and safety of aprepitant(fosaprepitant) combined with granisetron and dexamethasone for the prevention of nausea and vomiting in patients with gynecologic cancer receiving paclitaxel/carboplatin or docetaxel/carboplatin.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The proportion of patients with No Emesis in overall phase (0-120 hours after administration of carboplatin on day 1)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aprepitant on days 1 to 3
(or fosapreitant on day1)
Granisetron on day 1
Dexamethasone on days 1 to 4

Interventions/Control_2

Granisetron on day 1
Dexamethasone on days 1 to 4

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>

Gender

Female

Key inclusion criteria

1) Patient is scheduled to receive her first course of paclitaxel/carboplatin or docetaxel/carboplatin for gynecological cancer
2) Patient has not received highly or moderately emetogenic chemotherapy
3) Patient is able to sign to an approved informed consent
4) Patient is able to mention a diary

Key exclusion criteria

1) Patient has a serious hepatic insufficiency or renal failure
2) Patient has nausea or vomiting within 24 hours prior to chemotherapy
3) Patient has been treated with antiemetic agents within 48 hours prior to chemotherapy
4) Patient has any illness (e.g. central nervous system tumors, gastrointestinal obstruction, active peptic ulcer, brain metastasis) caused nausea or vomiting except for chemotherapy-induced nausea and vomiting
5) Patient is scheduled to receive radiation therapy to the abdomen
6) Patient has the collateral symptom that the dosage of the dexamethasone is impossible for four days
7) Patient has received Pimozide
8) Patient is judged inappropriate by the investigator as subject for this study

Target sample size

140

Name of lead principal investigator

1st name
Middle name
Last name	Hideaki Masuzaki

Organization

Nagasaki University (graduate school)

Division name

Department of Obstetrics and Gynecology

Zip code

Address

1-7-1 sakamoto, Nagasaki, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Shuhei Abe

Organization

Nagasaki University (graduate school)

Division name

Department of Obstetrics and Gynecology

Zip code

Address

1-7-1 sakamoto, Nagasaki, Japan

TEL

095-819-7363

Homepage URL

Email

koutabe@yahoo.co.jp

Institute

Nagasaki University (graduate school) department of Obstetrics and Gynecology

Institute

Department

Personal name

Organization

Nagasaki University (graduate school) department of Obstetrics and Gynecology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2011

Year

02

Month

21

Day

Date of IRB

Anticipated trial start date

2011

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

04

Month

23

Day

Last modified on

2012

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006477