UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031646 |
|---|---|
| Receipt number | R000036136 |
| Scientific Title | Evaluation of the efficacy and safety of 5mg olanzapine combined with aprepitant, granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in gynecologic cancer patients: a multicenter phase 2 study. |
| Date of disclosure of the study information | 2018/04/05 |
| Last modified on | 2020/01/16 17:00:35 |
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Basic information
Public title
Evaluation of the efficacy and safety of 5mg olanzapine combined with aprepitant, granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in gynecologic cancer patients: a multicenter phase 2 study.
Acronym
J-TOP-G : Japan, combination of Triplet therapy and Olanzapine for Prevention of carboplatin-induced nausea and vomiting in Gynecologic cancer patients
Scientific Title
Evaluation of the efficacy and safety of 5mg olanzapine combined with aprepitant, granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in gynecologic cancer patients: a multicenter phase 2 study.
Scientific Title:Acronym
J-TOP-G : Japan, combination of Triplet therapy and Olanzapine for Prevention of carboplatin-induced nausea and vomiting in Gynecologic cancer patients
Region
| Japan |
Condition
Condition
gynecologic cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the efficacy and safety of using 5mg olanzapine in combination with aprepitant, granisetron, dexamethasone in patients with gynecologic cancer who will be treated with carboplatin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response (no emesis, no rescue medication) rate within 120 hours from the start of CBDCA administration.
Key secondary outcomes
1. Complete response (no emesis, no rescue medication) rate within 168 hours from the start of CBDCA administration.
2. Complete response rate during the acute (0-24h) phase.
3. Complete response rate during the delayed (24-120h or 24-168h) phase.
4. Complete control (no emetic episodes, no rescue medication use, and no more than mild nausea) rate for the acute, delayed and overall phases.
5. Total control rate (no emetic episodes, no rescue medication use, and no nausea) rate for the acute, delayed and overall phases.
6. Severity of nausea.
7. Severity of anorexia.
8. Severity of sleepiness and the impact on life
9. Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
aprepitant+granisetron+dexamethasone+olanzapine(5mg)
Interventions/Control_2
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients with gynecologic cancer who are scheduled to receive carboplatin(AUC>=4)-based chemotherapy
2. Patients aged >= 20 years old and <= 80 years old
3. Patients with an ECOG Performance Status of 0 - 2
4. Patients with no symptomatic brain metastasis and carcinomatosis
5. Patients with no history of administration of moderate to high emetogenic chemotherapy
6. Patients who do not take a medicine regularly, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc.
7. Patients who meet the following standard values in general clinical tests:
AST and ALT <=100U/L
Total bilirubin <=2.0mg/dL
8. Written informed consent
Key exclusion criteria
1. History of hypersensitivity or allergy for study drugs or similar compounds.
2. Patients who need antiemetics at the enrollment.
3. Patients who start taking opioids within 48 hours prior to enrollment.
4. Patient with unstable angina, ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenal ulcer within 6 months prior to enrollment.
5. Patients who have convulsive disorders requiring anticonvulsants therapy
6. Patients with ascites effusion requiring paracentesis
7. Patients who have gastrointestinal obstruction
8.Pregnant, breastfeeding or expecting women or who do not wish to use contraception
9. Patients who have psychosis or psychiatric symptoms that interferes with daily life
10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment
11. Patients who had diabetes mellitus
12. Habitual smoker at enrollment
13. Other patients who are judged to be inappropriate for the study by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Morishige |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
500-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6000
mken@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Iihara |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
500-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6000
Homepage URL
dai0920@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
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
Gifu University
Address
1-1 Yanagido, Gifu, Gifu
Tel
058-230-6059
rinri@gifu-u.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
| 2018 | Year | 04 | Month | 05 | 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
60
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
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036136
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