UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy and safety of 5mg olanzapine combined with granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in thoracic tumor patients: a multicenter phase 2 study
Acronym	J-TOP-T:Japan, combination of doublet Therapy and Olanzapine for Prevention of carboplatin-induced nausea and vomiting in Thoracic cancer patients
Scientific Title	Evaluation of the efficacy and safety of 5mg olanzapine combined with granisetron and dexamethasone to prevent carboplatin-induced nausea and vomiting in thoracic tumor patients: a multicenter phase 2 study
Scientific Title:Acronym	J-TOP-T:Japan, combination of doublet Therapy and Olanzapine for Prevention of carboplatin-induced nausea and vomiting in Thoracic cancer patients
Region	Japan

Condition
Condition	thoracic tumor
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To Evaluate the efficacy and safety of using 5mg olanzapine in combination with granisetron, dexamethasone in patients with thoracic tumor 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 rate during the acute (0-24h) phase. 2. Complete response rate during the delayed (24-120h) phase. 3. Complete control (no emetic episodes, no rescue medication use, and no more than mild nausea) rate for the acute, delayed and overall phases. 4. Total control rate (no emetic episodes, no rescue medication use, and no nausea) rate for the acute, delayed and overall phases. 5. Time to treatment failure 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	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	Male and Female
Key inclusion criteria	1. Patients with lung cancer who are scheduled to receive carboplatin(AUC>=5)-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	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasushi Ohno
Organization	Gifu University Graduate School of Medicine
Division name	Department of Cardiology and Respirology
Zip code
Address	1-1 Yanagido, Gifu
TEL	058-230-6000
Email	yasusi@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	None
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 02 Month 14 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	2018 Year 02 Month 07 Day
Date of IRB	2018 Year 02 Month 07 Day
Anticipated trial start date	2018 Year 02 Month 15 Day
Last follow-up date	2020 Year 07 Month 31 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 02 Month 13 Day
Last modified on	2021 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035700