UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037749 |
|---|---|
| Receipt number | R000042970 |
| Scientific Title | A placebo-controlled, double-blind, randomized phase III study to validate the efficacy of standard antiemetic therapy plus olanzapine for the prevention of chemotherapy-induced nausea and vomiting associated with chemotherapy including carboplatin |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2024/03/06 15:03:58 |
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Basic information
Public title
A placebo-controlled, double-blind, randomized phase III study to validate the efficacy of standard antiemetic therapy plus olanzapine for the prevention of chemotherapy-induced nausea and vomiting associated with chemotherapy including carboplatin
Acronym
A phase III study to verify the usefulness of standard antiemetic therapy plus olanzapine for chemotherapy including carboplatin
Scientific Title
A placebo-controlled, double-blind, randomized phase III study to validate the efficacy of standard antiemetic therapy plus olanzapine for the prevention of chemotherapy-induced nausea and vomiting associated with chemotherapy including carboplatin
Scientific Title:Acronym
A phase III study to verify the usefulness of standard antiemetic therapy plus olanzapine for chemotherapy including carboplatin
Region
| Japan |
Condition
Condition
Advanced lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the superiority of standard antiemetic therapy plus olanzapine compared with standard antiemetic therapy with aprepitant, serotonin receptor antagonist and dexamethasone in chemotherapy including carboplatin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response rate during the 120 h after carboplatin administration.
Key secondary outcomes
Complete response rate during the acute, delayed phase. Complete control rate, safety.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For 4 days
Interventions/Control_2
Olanzapine 5mg or placebo
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)Advanced lung cancer patients who receive carboplatin containing chemotherapy.
2)20 years old or older.
3)Performance status 0-2.
4)Written informed consent.
Key exclusion criteria
1)Patients with the history of hypersensitivity or allergy for study drugs.
2)Patients who need and use antiemetic therapy during 48h before chemotherapy.
3)Patients with severe hepatic or renal dysfunction.
4)With convulsion.
5)Patients who need puncture to manage ascites.
6)Patients with complications inducing nausea and vomiting.
7)Patients with diabetes mellitus.
8)Patients who are judged to be inappropriate for this study.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu university school of medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Tanaka |
Organization
Hamamatsu university school of medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
TEL
053-435-2263
Homepage URL
41231644@hama-med.ac.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hamamatsu university school of medicine
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka
Tel
053-435-2680
rinri@hama-med.ac.jp
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
| 2019 | Year | 09 | 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
| 2019 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042970
