UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004998 |
|---|---|
| Receipt number | R000005943 |
| Scientific Title | A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2013/02/01 12:44:28 |
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Basic information
Public title
A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit
Acronym
A randomized phase II study of apreipitant in women younger than 70 years without alcohol drinking habit
Scientific Title
A multicenter, double-blind, placebo-controlled phase II study of apreipitant for prevention of chemotherapy-induced nausea and vomiting (CINV) following moderately emetogenic chemotherapy (MEC) in women younger than 70 years without alcohol drinking habit
Scientific Title:Acronym
A randomized phase II study of apreipitant in women younger than 70 years without alcohol drinking habit
Region
| Japan |
Condition
Condition
Female cancer patients younger than 70 years without alcohol drinking habit
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this sudy is to investigate the efficacy of aprepitant in female cancer patients younger than 70 years without alcohol drinking habit for CINV following carboplatin or inrinotecan based regimens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the proportion of patients with complete response (CR), defined as no vomiting and no use of rescue therapy, during 120 h after initiation of chemotherapy in cycle 1
Key secondary outcomes
The key secondary objectives are proportions of women with no vomiting with rescue use, or with total control (no nausea, no vomiting and no rescue use) during the 120 h post-chemotherapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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
Aprepitant arm: day 1, aprepitant 125 mg, granisetron 1 mg, and dexamethasone 12 mg before chemotherapy; days 2 through 3, aprepitant 80 mg qd and dexamethasone 4 mg qd
Interventions/Control_2
Control arm: day 1, granisetron 1 mg and dexamethasone 20 mg before chemotherapy; days 2 through 3, dexamethasone 8 mg qd
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Eligible women younger than 70 years old without alcohol drinking habi, naïve to APR with lung, colorectal, gynecologic or primary unknown cancer are treated with carboplatin (AUC 5-6) or irinotecan (more than 150 mg/m2) based regimens.
Key exclusion criteria
Any anthracylin and cyclophosphamide (AC) regimens are not permitted.
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Negoro |
Organization
Hyogo Cancer Center
Division name
Medical oncology
Zip code
Address
13-70 Kita-oji, Akashi, Hyogo
TEL
078-929-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Tanioka |
Organization
Hyogo Cancer Center
Division name
Medical oncology
Zip code
Address
13-70 Kita-oji, Akashi, Hyogo
TEL
078-929-1151
Homepage URL
tanioka@hp.pref.hyogo.jp
Sponsor or person
Institute
Hanshin Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Hanshin 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
兵庫県立がんセンター、先端医療センター、大阪府立成人病センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | 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
| 2011 | Year | 02 | Month | 01 | Day |
Last modified on
| 2013 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005943
