UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032269 |
|---|---|
| Receipt number | 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 | 2022/04/19 17:47:09 |
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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 | Obstetrics 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 | Naoki |
| Middle name | |
| Last name | Izawa |
Organization
St.Marianna University School
Division name
Clinical Oncology
Zip code
2168511
Address
St.Marianna University School of Medicine Hospital
TEL
044-977-8111
n2izawa@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
hiroko.shinoda@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine Hospital
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
St.Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
Tel
044-977-8111
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
https://bmjopen.bmj.com/content/10/12/e041737.long
Publication of results
Partially published
Result
URL related to results and publications
https://www.annalsofoncology.org/article/S0923-7534(21)04448-3/fulltext
Number of participants that the trial has enrolled
281
Results
Delayed CR rates in arm D4 and arm D1 were 79.7% and 75.0%, respectively (risk difference: -4.1%, 95% CI: -14.1% to 6.0%, P = 0.023). CR rates in arm D4 and arm D1 were 96.4% and 97.1%, (95% CI: -3.5% to 4.9%, P = 0.75) in the acute phase (0-24 h), and 79.0% and 72.8% (95% CI: -16.3% to 3.9%, P = 0.23) in the overall phase (0-120 h), respectively.
Results date posted
| 2022 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patient characteristics were well balanced between the two arms. Most patients (70%) were male (95 and 97 patients in arms D4 and D1, respectively), and the major primary tumor sites were the esophagus, head and neck, and lungs.
Participant flow
Between October 2018 and March 2021, we enrolled 281 patients; after excluding 3 before randomization, they were randomly assigned to arm D4 (n = 139) or D1 (n = 139). Three patients did not undergo chemotherapy in arm D1; thus, 275 patients (139 in arm D4 and 136 in arm D1) were analyzed for safety. One patient in arm D4 had major protocol deviations in the eligibility criteria. Ultimately, 274 patients (138 and 136 patients in arms D4 and D1, respectively) were included in the full analysis set.
Adverse events
In PRO-CTCAE, appetite loss (severity P < 0.01), nausea (frequency P < 0.01), diarrhea (frequency P = 0.02), and headache (frequency P< 0.01, severity P = 0.02) were observed more often in arm D1. In CTCAE evaluated by each investigator, nausea (P = 0.03) and anorexia (P < 0.01) were observed more often in arm D1. The frequency of severe nausea did not differ between the two arms, and there were no statistically significant differences between the two arms in the other items.
Outcome measures
CTCAE,PRO-CTCAE,EORTC QLQ-C30
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 03 | 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 | 04 | Month | 16 | Day |
Last modified on
| 2022 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036784
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/12/11 | SPAREDprotocol_Ver.4.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/12/11 | ConfigurationReport_SPARED_V12_R0_20210513091647.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/12/11 | SPARED data.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/36784
