UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004202 |
|---|---|
| Receipt number | R000004997 |
| Scientific Title | Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen. |
| Date of disclosure of the study information | 2010/09/05 |
| Last modified on | 2019/11/27 12:12:57 |
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Basic information
Public title
Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen.
Acronym
Phase II study of palonosetron, aprepitant and dexamethazone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy.
Scientific Title
Study of efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with germ cell tumors undergoing multiple-day cisplatin-based chemotherapy regimen.
Scientific Title:Acronym
Phase II study of palonosetron, aprepitant and dexamethazone to prevent nausea and vomiting induced by multiple-day emetogenic chemotherapy.
Region
| Japan |
Condition
Condition
germ cell tumors
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy and tolerability of combination therapy with palonosetron, aprepitant, and dexamethasone in patients receiving multiple-day cisplatin-based chemotherapy regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients with complete response (CR : no vomiting and no use of rescue therapy ) in the overall phase ( 0-240 hour after administration of cisplatin ).
Key secondary outcomes
(1)The proportion of patients with complete protection (no vomiting and no use of rescue therapy, no significant nausea) in the acute phase( 0-120 hour after administration of cisplatin ) and delayed phase ( 120-240 hour after administration of cisplatin ).
(2)Time to first vomiting.
(3)The proportion of patients with total control (no vomiting and no use of rescue therapy, no nausea)in the acute phase and delayed phase.
(4)The proportion of patients without vomiting (including patients with no use of rescue therapy) in the acute phase and delayed phase.
(5)The frequency of vomiting.
(6)No significant nausea.
(7)The proportion of patients without nausea in the acute phase and delayed phase.
(8)The degree of nausea.
(9)The proportion of patients without a rescue therapy in the acute phase and delayed phase.
(10)Time to first use of rescue therapy.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
palonosetron 0.75mg (day 1)(iv)
aprepitant 125mg (day 1)(oral)
aprepitant 80mg (day 2-7)(oral)
dexamethasone 6.6mg (day 1-7)(iv)
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)20 Years and older
2)Patients scheduled to receive a 5 day fractionated cisplatin-based combination chemotherapy in hospitalization.
3)Performance Status : 0-2
4)Life expectancy of at least 3 months
5)Patient can be described accurately symptom diary.
6)WBC ; 3,000/mm3 and Absolute Neutrophil Count (ANC); 1,500/mm3
Platelets ; 100,000/mm3
Aspartate aminotransferase (AST, SGOT) and Alanine aminotransferase (ALT, SGPT) < 2.5 x upper limit of normal
Bilirubin < 1.5 x upper limit of normal
Serum Creatinine < 1.5 x upper limit of normal
7)Patient will provide written informed consent and authorization to release personal health information.
Key exclusion criteria
1)Patients treated with stem cell transplantation in parallel with cisplatin chemotherapy.
2)No use of another antiemetic agent within 48 hours prior to beginning chemotherapy.
3)No use of benzodiazepine or opioids within 48 hours prior to beginning chemotherapy.
4)No use of systemic steroids within 72 hours prior to beginning chemotherapy.
5)No apply of radiotherapy within day -6 to 10.
6)No vomiting within 24 hours prior to beginning chemotherapy.
7)No known CNS metastasis.
8)No use of agents which may impair metabolism of aprepitant which include: Cisapride, macrolide antibiotics Clarithromycin, azole antifungal agents (Ketoconazole, Itraconazole)
9)No use of agents expected to induce the metabolism of aprepitant which include: Rifampin, Phenytoin, Carbamazepine, and barbiturates.
10)Subject with uncontrolled diabetes or a concurrent illness/condition requiring chronic systemic steroids.
11)No known hypersensitivity to any component of study regimen.
12)Patients judged inappropriate for this study by physicians.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Midori Hirai |
Organization
Kobe University Hospital
Division name
Department of Hospital Pharmacy
Zip code
Address
7-5-2 kusunoki-cho Chuo-ku Kobe Hyogo 650-0017 JAPAN
TEL
078-382-6669
ioroit@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Ioroi |
Organization
Kobe University Hospital
Division name
Department of Hospital Pharmacy
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6669
Homepage URL
chiken@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00520-017-3967-2
Number of participants that the trial has enrolled
Results
Twenty-five patients were enrolled and evaluated for safety, and 24 patients were evaluated for efficacy. CR was achieved in 62.5% of patients (95% confidence interval [CI]？=？40.6-81.2, p？=？0.043) in the overall period. CP and TC were achieved in 62.5% (95% CI？=？40.6-81.2) and 25.0% of patients (95% CI？=？9.8-46.7), respectively, in the overall period. The primary adverse drug reaction was hiccups (48.0%). The events were expected, and none was grade 3 or 4.
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
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004997
