UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024676 |
|---|---|
| Receipt number | R000028387 |
| 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 |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/05/04 13:08:34 |
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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 | Obstetrics 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
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
ma.abe@scchr.jp
Public contact
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
hhashimo@ncc.go.jp
Sponsor or person
Institute
AMED (Japan Agency for Medical Research and Development)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028387
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