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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031646
Receipt No. 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 2018/04/05

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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
Obsterics 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
Middle name
Last name Kenichiro Morishige
Organization Gifu University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6000
Email mken@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotoshi Iihara
Organization Gifu University Hospital
Division name Department of Pharmacy
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6000
Homepage URL
Email dai0920@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 05 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 05 Day
Last follow-up date
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
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036136

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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