UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005268
Receipt number R000006265
Scientific Title Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool
Date of disclosure of the study information 2011/03/17
Last modified on 2013/10/17 18:49:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool

Acronym

Efficacy of palonosetoron compared with granisetron for prevention of CINV using MAT

Scientific Title

Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool

Scientific Title:Acronym

Efficacy of palonosetoron compared with granisetron for prevention of CINV using MAT

Region

Japan


Condition

Condition

Lung cancer, Colon cancer, Breast cancer

Classification by specialty

Pneumology Hematology and clinical oncology Gastrointestinal surgery
Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy of Palonosetoron compared with granisetoron using MAT and FLIE in HEC or MEC.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Score of delayed CINV in MAT

Key secondary outcomes

1)Score of nausea in FLIE
2)Score of vomiting in FLIE
3)Number of delayed vomiting
4)Number of acute vomiting
5)Number of acute nausea
6)Number of acute vomiting
7)Plasma concentration of 5-HIAA, Substance P and ghrelin


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Paronosetoron 0.75mg d.i.v. 30 min prior to chemotherapy on Day1

Interventions/Control_2

Granisetoron 3mg d.i.v. 30 min prior to chemotherapy on Day1

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patient receiving HEC or MEC defined by Japan Society of Clinical Oncology guideline 2010, ver 1
2)ECOG performance status of 0-2
3)Acquisition of written informed consent

Key exclusion criteria

1)Patient with dementia
2)Concurrent brain radiotherapy
3)Serious infections
4)Clinical brain metastasis
5)Massive pericardial, pleural effusion, or ascites
6)Vestibular disorder
7)Clinical hypercalcaemia or hyponatremia
8)Clinical uremia
9)Ireus or sub-ireus
10)Serious clinical probrems
11)Previous drug allergy
12)Hoped to be pregnant/ nursing
13)Those judged to be not suitable by the attending physician

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukari Tsubata

Organization

Shimane University Faculty of Medicine

Division name

Division of Clinical Oncology and Respiratory Medicine

Zip code


Address

89-1, Enya-cho, Izumo, Shimane

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Shimane University Faculty of Medicine

Division name

Division of Clinical Oncology and Respiratory Medicine

Zip code


Address

89-1, Enya-cho, Izumo, Shimane

TEL


Homepage URL


Email



Sponsor or person

Institute

Shimane University Faculty of Medicine
Division of Clinical Oncology and Respiratory Medicine

Institute

Department

Personal name



Funding Source

Organization

Shimane University Faculty of Medicine
Division of Clinical Oncology and Respiratory Medicine

Organization

Division

Category of Funding Organization

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

2011 Year 03 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date

2013 Year 08 Month 31 Day

Date of closure to data entry

2013 Year 08 Month 31 Day

Date trial data considered complete

2013 Year 08 Month 31 Day

Date analysis concluded

2013 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 03 Month 17 Day

Last modified on

2013 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006265


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name