UMIN-CTR Clinical Trial

Basic information
Public title	A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: J-SUPPORT 1604
Acronym	J-FORCE STUDY: J-SUPPORT and the Fourth agent Olanzapine Resist Cisplatin Emetogenesity.
Scientific Title	A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: J-SUPPORT 1604
Scientific Title:Acronym	J-FORCE STUDY: J-SUPPORT and the Fourth agent Olanzapine Resist Cisplatin Emetogenesity.
Region	Japan

Condition
Condition	Malignant solid tumor
Classification by specialty	Gastroenterology Pneumology Obsterics and gynecology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this randomized, double-blind, placebo-controlled phase III trial is to confirm the efficacy of olanzapine 5mg combined with aprepitant, palonosetron, dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Complete response (CR: no emesis, no rescue medication) rate during the delayed phase (24-120h post-cisplatin administration).
Key secondary outcomes	1. Complete response rate during the acute (0-24h post-cisplatin administration) phase and for the overall phase (0-120h post-cisplatin administration). 2. Complete control (defined as no emetic episodes, no rescue medication, and no more than mild nausea) rate for the overall phases and in daily period. 3. Total control rate (defined as no emetic episodes, no rescue medication, and no nausea) rate for the overall phase and in daily period. 4. Time to treatment failure (i.e., time to first emetic episode or time to administration of rescue therapy, whichever occurred first). 5. Severity of nausea. 6. Severity of anorexia. 7. Severity and influence to daily life of sleepiness. 8. Adverse event.

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 not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Olanzapine 5mg+Aprepitant+Palonosetron+Dexamethasone
Interventions/Control_2	Placebo +Aprepitant+Palonosetron+Dexamethasone
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Malignant tumor patients except for hematopoietic malignancy. 2. Cisplatin-naive patients who receive the cisplatin (>=50mg/m2)-based chemotherapy. 3. Patients who are 20-75 years old at the enrollment. 4. ECOG performance status 0-2. 5. Patients with no symptomatic brain metastasis/carcinomatosis. 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. within 48 hours prior to enrollment. 7. Adequate organ function as defined by (each of the following values are examined within 7 days before prior to entry) ;1) T-Bil <=2.0 mg/dL, 2) AST <=100 IU/L, 3) ALT <=100 IU/L. 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 who suffered from ischemic heart disease, cerebral hemorrhage or apoplexy, active gastric or duodenum ulcer within 6 months prior to enrollment. 5. Patients who has a convulsive disorders that need anticonvulsants therapy. 6. Patients with symptomatic ascites that need therapeutic drainage. 7. Patients with gastro-intestinal stenosis or obstruction. 8. Pregnant, breastfeeding or expecting woman. 9. Psychotic patients using antipsychotic drug. 10. Patient who received abdominal or pelvic irradiation within 6 days prior to enrollment or patients who receive abdominal or pelvic concurrent chemoradiotherapy. 11. Patients who had diabetes mellitus with use of antidiabetics and patients with HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. 12. Patients who cannot be hospitalized during 6 days (0-120 h post-cisplatin administration). 13. Habitual smoker at the enrollment. 14. Patients judged by the investigator to be inappropriate for this study.
Target sample size	690

Research contact person
Last name of lead principal investigator	1st name Masakazu Middle name Last name Abe
Organization	Shizuoka Cancer Center
Division name	Department of Gynecologic Oncology
Zip code	411-8777
Address	1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
TEL	055-989-5222
Email	ma.abe@scchr.jp

Public contact
1st name of contact person	1st name Hironobu Middle name Last name Hashimoto
Organization	National Cancer Center Hospital
Division name	Department of Pharmacy
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL	http://www.j-support.org
Email	hhashimo@ncc.go.jp

Sponsor
Institute	AMED (Japan Agency for Medical Research and Development)
Institute
Department

Funding Source
Organization	AMED (Japan Agency for Medical Research and Development)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shizuoka Cancer Center
Address	1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka
Tel	055-989-5222
Email	rinsho_office@scchr.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCCH1604
Org. issuing International ID_1	National Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 11 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	2016 Year 11 Month 01 Day
Date of IRB	2017 Year 01 Month 17 Day
Anticipated trial start date	2017 Year 02 Month 02 Day
Last follow-up date	2018 Year 07 Month 30 Day
Date of closure to data entry	2018 Year 10 Month 15 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2019 Year 01 Month 15 Day

Other
Other related information

Management information
Registered date	2016 Year 11 Month 01 Day
Last modified on	2019 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028387