UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009403
Receipt number	R000011048
Scientific Title	A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy
Date of disclosure of the study information	2012/11/27
Last modified on	2015/05/27 10:00:02

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Basic information

Public title

A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

colorectal cancer, lung cancer, breast cancer

Classification by specialty

Gastroenterology Pneumology Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To show non-inferiority between the two treatments from day 1–5 in terms of complete response

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Assessment

Primary outcomes

Percentage of patients with complete response (no vomiting and no rescue medication) during day1-5 after moderately emetogenic chemotherapy

Key secondary outcomes

1)Complete response rate (acute phase, late phase)
2)Complete control rate (no vomiting, no rescue medication and no or mild nausea)
3)Adverse events

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

dexamethasone day1-3 plus palonosetron

Interventions/Control_2

dexamethasone day1 plus palonosetron

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 and Female

Key inclusion criteria

1)Age of 20 years or older
2)Diagnosis of malignancy
3)No systemic chemotherapy or prior low or minimal emetogenic chemotherapy
4)Moderately emetogenic chemotherapy is planned (The moderately emetogenic chemotherapy over 2 or more days is excluded)
5)Adequate bone marrow, lever and renal function
6)ECOG performance status of 0-2
7)Written informed consent

Key exclusion criteria

1)Serious or uncontrolled complication
2)Symptomatic or clinically suspected bone metastasis
3)Convulsive disorder needs anti-convulsant
4)Ascites fluid or pleural effusion needs paracentesis
5)Gastrointestinal obstruction
6)Vomiting and/or grade 2 or more nausea before chemotherapy
7)Hypersensitivity for 5-HT3 receptor antagonist
8)Hypersensitivity for dexamethasone
9)Pregnancy, lactation or who does not wish to contraception
10)History of palonosetorn administration
11)Capability or intention of cooperating
12)Participant in other anti-emetic trial
13)Undersirable for the patient to enter the trial

Target sample size

300

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yoshito Komatsu

Organization

Hokkaido University Hospital Cancer Center

Division name

Department of Cancer Chemotherapy

Zip code

Address

North 14, West 5, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5657

Email

ykomatsu@med.hokudai.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Kenji Okita

Organization

Sapporo Medical University

Division name

First Department of Surgery

Zip code

Address

South 1,West 17,Chu-ouku,Sapporo,Hokkaido,Japan

TEL

81-11-611-2111

Homepage URL

Email

okita@sapmed.ac.jp

Sponsor or person

Institute

Hokkaido 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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 27 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 01 Month 24 Day

Date of IRB

Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 11 Month 27 Day

Last modified on

2015 Year 05 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011048

Gastroenterology	Pneumology	Hematology and clinical oncology
Breast surgery