UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013249 |
|---|---|
| Receipt number | 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 17:28:52 |
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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
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
satoshi-yuuki175@joy.ocn.ne.jp
Sponsor or person
Institute
HOPE group(Hokkaido Supportive Care Oncology Project - an Expert Group Initiative)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015415
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