UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014214 |
|---|---|
| Receipt number | R000016559 |
| Scientific Title | A double-blind randomized phase II study of olanzapine 10mg versus 5mg for highly emetogenic chemotherapy-induced nausea and vomiting. |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2015/05/07 19:47:51 |
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Basic information
Public title
A double-blind randomized phase II study of olanzapine 10mg versus 5mg for highly emetogenic chemotherapy-induced nausea and vomiting.
Acronym
Trial of olanzapine 10mg versus 5mg for emesis induced by HEC.
Scientific Title
A double-blind randomized phase II study of olanzapine 10mg versus 5mg for highly emetogenic chemotherapy-induced nausea and vomiting.
Scientific Title:Acronym
Trial of olanzapine 10mg versus 5mg for emesis induced by HEC.
Region
| Japan |
Condition
Condition
Malignant solid tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this randomized phase II study is to compare the efficacy and safety of olanzapine 10mg vs. 5mg, each combined with aprepitant, palonosetron, dexamethasone, in the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Complete response (CR: no emesis, no rescue medication) rate during the delayed (24-120h) phase.
Key secondary outcomes
1. Complete response rate during the acute (0-24h) phase and for the overall (0-120h) phases.
2. Complete control (defined as no emetic episodes, no rescue medication use, and no more than mild nausea) rate for the overall (0-120h) phases and in daily periods.
3. Total control rate (defined as no emetic episodes, no rescue medication use, and no nausea) rate for the overall (0-120h) phases and in daily periods.
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 of sleepiness.
8. Adverse event.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Historical
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olanzapine 10mg + Aprepitant + Palonosetron + Dexamethasone
Interventions/Control_2
Olanzapine 5mg + 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. performance status(ECOG PS) of 0-2.
3. 20 years-old over at the time of giving informed consent.
4. patients who receive the chemotherapy involving cisplatin as first line.
5. Cisplatin >=50mg/m2 .
6. the regimens involve the standard treatment for vomiting with dexamethasone, aprepitant and 5HT3 receptor antagonist.
7. adequate organ function as defined by;(each of the following values are examined within 8 days before prior to entry).
1) AST <100 IU/L, ALT <100 IU/L
2) T-Bill <2.0 mg/dL
3) Ccr >=60 mL/min
8. written informed consent.
9. patients who are able to fill out patient-reported outcomes.
Key exclusion criteria
1. history of hypersensitivity or allergy for study drugs or similar compounds.
2. patients who do not have enough general condition to the antineoplastic agents treatment.
3. symptomatic brain metastasis.
4. patients who has a convulsive disorders that need anticonvulsants therapy.
5. patients with a symptom who has ascites or pleural effusion that need puncture.
6. patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc.
7. pregnant, breastfeeding or expecting woman.
8. patients enforced radiotherapy in the abdominal or pelvic field between 6 days before and 6 days after chemotherapy.
9. patients who take a medicine, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine agents, etc within 48 hours prior to beginning chemotherapy.
10. patients who take opioids within 48 hours prior to beginning chemotherapy.
11. patient who is taking pimozide, clarithromycin, ketoconazole, itraconazole, barbiturate (primidone, phenobarbital), rifampicin, phenytoin, carbamazepine, fluvoxamine maleate, ciprofloxacin.
12. patients who take a medicine regularly, for example, 5HT3 receptor antagonists, corticosteroids, antidopamine agonists, phenothiazine tranquilizers, antihistamine drugs, benzodiazepine, agents, etc.
13. patients who take adrenaline within 48 hours prior to beginning chemotherapy.
14. patients who had diabetes mellitus or past history of diabetes mellitus or HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1.
15. patients who cannot be hospitalized during 6 days (0-120 h).
16. judged by the investigator to be inappropriate for this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Yamamoto |
Organization
National Cancer Center Hospital
Division name
Department of Thoracic Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
nbyamam@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Yanai |
Organization
National Cancer Center Hospital
Division name
Department of Pharmacy
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
tyanai@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Cancer Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
栃木県立がんセンター（栃木県）、群馬県立がんセンター（群馬県）、埼玉県立がんセンター（埼玉県）、国立がん研究センター東病院（千葉県）、がん研有明病院（東京都）、国立がん研究センター中央病院（東京都）、日本医科大学付属病院（東京都）、大阪市立総合医療センター（大阪府）、四国がんセンター（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 16 | 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
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 09 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016559
