UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009585
Receipt number R000011248
Scientific Title Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer
Date of disclosure of the study information 2013/03/01
Last modified on 2012/12/19 22:24:36

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Basic information

Public title

Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer

Acronym

Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer

Scientific Title

Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer

Scientific Title:Acronym

Phase III study to clarify the efficacy and safety of aprepitant or palonosetron on chemotherapy with paclitaxel and carboplatin for gynecologic cancer

Region

Japan


Condition

Condition

Cervical cancer, Corpus cancer, Ovarian cancer, Tubal cancer, Peritoneal cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and safety of aprepitant or palonosetron for chemotherapy with Paclitaxel and Carboplatin

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Anti emetic efficacy for 5 days after chemotherapy

Key secondary outcomes

1. Anti emetic efficacy on the day of chemotherapy
2. Anti-emetic efficacy during day2 to 5 after chemotherapy
3. Ratio of emesis, vomiting and rescue therapy for 5 days after chemotherapy
4. Time until rescue therapy
5. Food intake after chemotherapy
6. Influence of risk factor (Background of patient)
7. Total amount for anti emetic therapy
8. Influence by difference of the schedule of carboplatin and Paclitaxel
9. Change the efficacy on several courses
10. Efficacy of rescue therapy with aprepitant or palonosetron


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aprepitant and granisetron and dexamethasone

Interventions/Control_2

Palonosetron and dexamethasone

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

80 years-old >

Gender

Female

Key inclusion criteria

Gynecologic cancer patients necessary the chemotherapy with paclitaxel and carboplatin

Key exclusion criteria

1. Past history of previous chemotherapy
2. Hypersensitivity for Aprepitant or Palonosetron

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Minoru Irahara

Organization

Tokushima University Hospital

Division name

Obstetris and Gynecology

Zip code


Address

3-18-15 Kurmoto-cho Tokushima

TEL

088-633-7177

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masato Nishimura

Organization

Tokushima University Hospital

Division name

Obstetrics and Gynecology

Zip code


Address

3-18-15 Kuramoto-cho Tokushima

TEL

088-633-7177

Homepage URL


Email



Sponsor or person

Institute

Obstetrics and Gynecology, Tokushima University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2013 Year 03 Month 01 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

Preinitiation

Date of protocol fixation

2013 Year 01 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 03 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 12 Month 19 Day

Last modified on

2012 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011248


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name