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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013249
Receipt No. R000015415
Scientific Title A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02)
Date of disclosure of the study information 2014/02/25
Last modified on 2017/02/27

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Basic information
Public title A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02)
Acronym A randomized phase III trial of PALO versus PALO plus DEX for the prevention of nausea and vomiting induced by MEC (HOPE-02)
Scientific Title A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02)
Scientific Title:Acronym A randomized phase III trial of PALO versus PALO plus DEX for the prevention of nausea and vomiting induced by MEC (HOPE-02)
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate non-inferiority of palonosetron to palonosetron plus dexamethasone (day1) in terms of complete response rate for moderately emetogenic chemotherapy (MEC) regimens.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Complete response rate (overall period)
Key secondary outcomes Complete response rate (acute, delayed phase)
Complete control rate (overall period, acute, delayed phase)
Total control rate (overall period, acute, delayed phase)
No rescue medication rate
Antiemetic agents-related adverse events
Influence of steroids long-term use
*Change of antiemetic agents
*Transition of HbA1c
*Adverse events (allergic reaction, nausea, vomiting, anorexia)

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Palonosetron 0.75mg/body
Dexamethasone 9.9mg/body
Interventions/Control_2 Palonosetron 0.75mg/body
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.Prior chemotherapy with low or minimal emetogenicity, or no prior systemic chemotherapy
4.Moderately emetogenic chemotherapy is planned
*Moderately emetogenic chemotherapy over 2 or more days is excluded
* CDDP regimens are excluded regardless of its dosage
*Also CBDCA regimens are excluded
5.Adequate bone marrow, liver and renal functions
6.ECOG performance status of 0-2
7.Written informed consent
Key exclusion criteria 1)Serious or uncontrolled complication
2)Symptomatic or clinically suspected brain metastasis
3)Convulsive disorder requiring anti-convulsant
4)Ascites fluid or pleural effusion requiring paracentesis
5)Gastrointestinal obstruction
6)Vomiting and/or grade 1 or more nausea at baseline
7)Patients with planned radiotherapy
8)History of hypersensitivity to 5-HT3 receptor antagonist
9)History of hypersensitivity to dexamethasone
10) Continuous administration of steroids
11) Poorly controlled nausea by opioids
12)Pregnancy, lactation or who does not wish to contraception
13)History of palonosetorn administration
14)Without capability or intention of cooperating with study procedure
15)Participant in other anti-emetic trial
16)Undesirable for the patient to enter the trial
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshito Komatsu
Organization Hokkaido University Hospital
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 Satoshi Yuki
Organization Hokkaido University Hospital
Division name Department of Gastroenterology
Zip code
Address North 14, West 5, Kita-Ku, Sapporo, Hokkaido, Japan
TEL 011-706-5657
Homepage URL
Email satoshi-yuuki175@joy.ocn.ne.jp

Sponsor
Institute HOPE group(Hokkaido Supportive Care Oncology Project - an Expert Group Initiative)
Institute
Department

Funding Source
Organization Hokkaido Gastrointestinal Cancer Study Group
Organization
Division
Category of Funding Organization Other
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 北海道大学病院(北海道)他HOPE group参加施設

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 25 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 Completed
Date of protocol fixation
2013 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2017 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015415

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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