UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003820 |
|---|---|
| Receipt number | R000004605 |
| Scientific Title | Efficacy and tolerability of combination therapy with aprepitant,palonosetron,and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy for gynecological cancer(Phase II Study) |
| Date of disclosure of the study information | 2010/06/24 |
| Last modified on | 2012/06/25 08:09:08 |
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Basic information
Public title
Efficacy and tolerability of combination therapy with aprepitant,palonosetron,and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy for gynecological cancer(Phase II Study)
Acronym
Phase II Study of aprepitant and palonosetron to prevent nausea and vomiting induced by chemotherapy for gynecological cancer
Scientific Title
Efficacy and tolerability of combination therapy with aprepitant,palonosetron,and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy for gynecological cancer(Phase II Study)
Scientific Title:Acronym
Phase II Study of aprepitant and palonosetron to prevent nausea and vomiting induced by chemotherapy for gynecological cancer
Region
| Japan |
Condition
Condition
gynecological cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy and tolerability of combination therapy with aprepitant, palonosetron, and dexamethasone in patients receiving cisplatin-based (more than 50 mg/m2 ) chemotherapy for gynecological canncer.
Basic objectives2
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 ( 0-120 hour after administration of cisplatin ).
Key secondary outcomes
1)the proportion of patients with complete response (CR: no vomiting and no use of rescue therapy ) in the acute phase ( 0-24 hour after administration of cisplatin ) and delayed phase ( 24-120 hour after administration of cisplatin ).
2)the proportion of patients with complete protection (no vomiting, no use of rescue therapy, and no significant nausea(Nausea VAS[Visual Analogue Scale]<25mm)) in the acute phase, delayed phase, and overall phase.
3)the proportion of patients reported "no or little impact of CINV on daily life" as measured by FLIE ( Functional Living Index-Emesis ) score on Day 6.
4)Adverse reactions, Harmful events
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
aprepitant 125mg (day 1)(oral)
aprepitant 80mg (day 2-3)(oral)
palonosetron 0.75mg (day 1)(iv)
dexamethasone 9.9mg (day 1)(oral or iv)
dexamethasone 6.6mg (day 2-4)(oral or 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Chemotherapy-naive ( including cisplatin ) patients with gynecological cancer.
2. Patients with received the chemotherapy including cisplatin ( more than 50 mg/m2 ).
3. Patients with written informed consent.
Key exclusion criteria
1. Patients with history of chemotherapy with cisplatin.
2. Patients with dysfunction of liver ( Child-Pugh Score > 9 ).
3. Patients with received Pimozide.
4. Patients with ALT ( GPT ) or AST ( GOT ) > 3 X the upper limit of normal or Total bilirubin > 2 X the upper limit of normal prior to registration.
5. Patients with serum creatinine > 1.5 X the upper limit of normal prior to registration.
6. Patients with active infection disease.
7. Patients who needs invasive treatment for massive effusion ( Eligible in case of controlled massive effusion ).
8. Patients with pregnant or lactating women or women of childbearing potential.
9. Patients received last observation by another clinical study within 90 days prior to agreement acquisition.
10. Patients who cannot, won't, or don't seem to satisfy by hospital visiting, strict observance of the experimental drug dosage, or limitation of time constraints.
11. Patients judged inappropriate for this study by physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Takai |
Organization
Oita University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita
TEL
097-586-5922
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Takai |
Organization
Oita University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu-shi, Oita
TEL
Homepage URL
Sponsor or person
Institute
Kansai Clinical Oncology Group -Gynecologic Cancer Group-
Institute
Department
Personal name
Funding Source
Organization
Kansai Clinical Oncology Group -Gynecologic Cancer Group-
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
YES
Study ID_1
KCOG-G1003
Org. issuing International ID_1
Kansai Clinical Oncology Group -Gynecologic Cancer Group-
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 | 06 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.kcog.jp/
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
| 2010 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 24 | Day |
Last modified on
| 2012 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004605
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