UMIN-CTR Clinical Trial

Public title

The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy

Acronym

The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy

Scientific Title

The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy

Scientific Title:Acronym

The efficacy of fosaprepitant to the moderate emetic risk intravenous chemotherapy

Region

Japan

Condition

Patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone) for the moderate emetic risk intravenous chemotherapy(L-OHP, CPT-11, CBDCA)

Classification by specialty

Gastroenterology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We research the situation of the digestive symptom(nausea and vomoiting) in patients who received moderate emetic risk intravenous chemotherapy and the efficacy of fosaprepitant to the patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

>Patients rate who required triple-drug therapy because of a digestive symptom(nausea and vomiting)
>Improvement rate of the digestive symptom(nausea and vomiting) by the triple-drug therapy

Key secondary outcomes

>Patients rate without vomiting
>Patients rate of Complete Response (without vomiting and rescue)
>Patients rate of Complete Protection (without vomiting, rescue, moderate or severe nausea)
>Patients rate without nausea
>Patients rate without moderate or severe nausea
>Frequency distribution of nausea and vomiting
>Successful treatment period
>Intake situation

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We administer three antiemetic drugs(5-HT3 antagonist, dexamethasone and fosaprepitant) from the next course for the patients who experienced nausea and vomiting by two antiemetic drugs(5-HT3 antagonist 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients who are not effective by two antiemetic drugs(5-HT3 antagonist and dexamethasone) for the moderate emetic risk intravenous chemotherapy(L-OHP, CPT-11, CBDCA)
2)We use palonosetron as 5-HT3 antagonist
3)Clinical stage: do not ask
4)Molecular target drug: do not ask
5)Documented informed consent

Key exclusion criteria

1)Serious complications (e.g. severe liver disfunction or renal disfunction)
2)Patients with factors besides chemotherapy(e.g. brain tumor, passage disorder of digestive tract, active digestive ulcer, brain metastases)
3)Poorly controlled diabetes
4)Pregnant or lactating women or women of childbearing potential
5)Patients during pimozide administration
6)Inadequate physical condition, as diagnosed by primary physician

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Chikashi Ishioka

Organization

Institute of Development, Aging and Cancer, Tohoku University

Division name

Department of Clinical Oncology

Zip code

Address

4-1 Seiryo-machi, Aoba-ku, Sendai, Japan

TEL

022-717-8543

Email

Name of contact person

1st name
Middle name
Last name	Masanobu Takahashi

Organization

Tohoku University Hospital

Division name

Department of Clinical Oncology

Zip code

Address

4-1 Seiryo-machi, Aoba-ku, Sendai, Japan

TEL

022-717-8543

Homepage URL

http://www.co.idac.tohoku.ac.jp/

Email

mtakahashi@idac.tohoku.ac.jp

Institute

Division of Clinical Oncology, Tohoku University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

2012

Year

11

Month

15

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

Enrolling by invitation

Date of protocol fixation

2012

Year

09

Month

14

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

11

Day

Last modified on

2013

Year

05

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010786