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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032269
Receipt No. R000036784
Scientific Title Placebo-Controlled, Double-Blinded Phase III Study Comparing Dexamethasone on Day 1 With Dexamethasone on Days 1 to 4 With Combined Neurokinin-1 Receptor Antagonist, Palonosetron and Olanzapine in High- Emetogenic Chemotherapy
Date of disclosure of the study information 2018/04/16
Last modified on 2019/04/21

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Basic information
Public title Placebo-Controlled, Double-Blinded Phase III Study Comparing Dexamethasone on Day 1 With Dexamethasone on Days 1 to 4 With Combined Neurokinin-1 Receptor Antagonist, Palonosetron and Olanzapine in High- Emetogenic Chemotherapy
Acronym SPARED trial
Scientific Title Placebo-Controlled, Double-Blinded Phase III Study Comparing Dexamethasone on Day 1 With Dexamethasone on Days 1 to 4 With Combined Neurokinin-1 Receptor Antagonist, Palonosetron and Olanzapine in High- Emetogenic Chemotherapy
Scientific Title:Acronym SPARED trial
Region
Japan

Condition
Condition Malignant solid tumor
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Obsterics and gynecology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify that noninferiority of dexamethasone on day1, with sparing day 2-4, combined with NK1 receptor antagonist, palonosetron, olanzapine, compared with the 4-day use of dexamethasone for cisplatin-based highly emetogenic chemotherapy regimens.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Complete response (CR: no emetic episodes and no rescue medication) rate during the delayed phase (24-120hr post-cisplatin administration)
Key secondary outcomes 1.CR rate during acute phase (0-24hr) and over all phase (0-120hr)
2.Complete control (CC: no emetic episodes, no rescue medication, and no more than mild nausea) rate for the overall phase, the acute phase and the delayed phase
3.Total control (TC: no emetic episodes, no rescue medication, and no nausea) rate for the overall phase, the acute phase and the delayed phase
4.No vomiting rate for the overall phase, the acute phase and the delayed phase
5.No nausea rate for the overall phase, the acute phase and the delayed phase
6.Time to treatment failure
7.Severity of nausea during the over all phase
8.Quality of life score using EORTC QLQ-C30
9.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 considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 NK1receptor antagonist+palonosetron+olanzapine+dexamethasone day 1 to 4
Interventions/Control_2 NK1receptor antagonist+palonosetron+olanzapine+dexamethasone day 1
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) Cisplatin-naive solid malignant tumor patients who receive the cisplatin (>=50mg/m2)-based chemotherapy
2) Patients who are 20 to 74 years old at the enrollment
3) Grade 0 of nausea and vomiting by CTCAE ver4.0 within 24 hr before enrollment
4) Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0 or 1
5) Adequate organ function defined as;(each of following values are examined within 2 weeks prior to enrollment)
ALT < 100 IU/L
AST < 100 IU/L
T-Bil < 2.0 mg/dL
Cr < 1.5 mg/dL
6) Patient with more than three months of life expectancy
7) All subjects must be provided written informed consent prior to enrollment
Key exclusion criteria 1) Patients taking systemic corticosteroid (oral and intravenous)
2) Patients taking antiemetics
3) Patients who receive moderately emetogenic chemotherapy within six days before and after cisplatin administration (Minimally to low emetogenic agents are allowed)
4) Patients who receive radiation therapy to abdomen or pelvis within six days prior to enrollment until six days after cisplatin
5) Patients with symptomatic brain metastasis
6) Patients who have diabetes mellitus with use of any antidiabetic or patients with HbA1c (NGSP) >= 6.5
7) Patients who have any convulsive disorder with medication
Target sample size 280

Research contact person
Name of lead principal investigator
1st name Takako
Middle name
Last name Eguchi Nakajima
Organization St.Marianna University School
Division name Clinical Oncology
Zip code 2168511
Address St.Marianna University School of Medicine Hospital
TEL 044-977-8111
Email tnakajima@marianna-u.ac.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name Minatogawa
Organization St.Marianna University School of Medicine Hospital
Division name Department of Pharmacy
Zip code 2168511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL 044-977-8111
Homepage URL
Email hiroko.shinoda@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine Hospital
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 St.Marianna University School of Medicine
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.ac.jp

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 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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 16 Day
Date of IRB
2018 Year 07 Month 27 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2020 Year 09 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
2018 Year 04 Month 16 Day
Last modified on
2019 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036784

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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