UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012806 |
|---|---|
| Receipt number | R000014962 |
| Scientific Title | Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer. |
| Date of disclosure of the study information | 2014/01/09 |
| Last modified on | 2019/01/15 16:46:18 |
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Basic information
Public title
Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.
Acronym
Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.
Scientific Title
Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.
Scientific Title:Acronym
Phase2 study of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.
Region
| Japan |
Condition
Condition
gynecological cancer (ovarian cancer, endometrial cancer and uterine cervix cancer)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of palonosetoron and dexamethasone therapy for prevention of carboplatin-induced nausea and vomiting in patients with gynecological cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete control rate during the delay phase
Key secondary outcomes
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Palonosetron
0.75mg iv. prior to chemotherapy on Day1.
Dexamethasone
Day1 19.8mg or 9.9 mg iv. prior to chemotherapy.
Day2 8.0mg orally or 6.6mg iv.
Day3 8.0mg orally or 6.6mg 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
Female
Key inclusion criteria
1 more than Age 20
2 Patients with histologically proven gynecological cancer
3 No prior chemotherapy
4 Patient receiving carboplatin AUC5 6
5 Patient have enough organ function based on blood test within 8 days before registration
Neutrophils more than 2,000
Platelets more than 100,000
AST and ALT less than 100
Serum creatinine less than1.5
6 ECOG performance status 0 2
7 Written informed consent
Key exclusion criteria
1 Uncontrolled severe complication disease without cancers
2 Symptomatic brain metastasis
3 Epilepsy patient treated with antiepileptic agent, excluding being
4 Patient with massive pleural effusion or ascites to be required drainage
5 Intestinal paralysis or ileus
6 Grade 2 or more nausea and vomiting
7 Hypersensitivity for palonosetron and other 5 HT3 antagonist
8 Hypersensitivity for dexamethasone
9 Pregnant ,lactating woman or women who do not agree that we prevent conception
10 Patient with history of palonosetoron treatment
11 Patient without compliance of this study rule
12 Other patients who are unfit for the study as determined by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiharu Kamura |
Organization
Yanagawa Hospital
Division name
Yanagawa Hospital
Zip code
Address
29 Chikushi machi Yanagawa
TEL
0944-72-6171
tokamura@yanagawa-hsp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimio Ushijima |
Organization
Kurume University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
67 Asahimachi Kurume
TEL
0942-31-7573
Homepage URL
http://chotsg.co./wjgog/study.html
kimi@med.kurume-u.ac.jp
Sponsor or person
Institute
West Japan Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
West Japan Gynecologic Oncology Group
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 01 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3802/jgo.2018.29.e77
Number of participants that the trial has enrolled
Results
While palonosetron effectively controls acute CINV, additional antiemetic management is warranted in the delayed phase after carboplatin-based chemotherapy in gynecologic cancer patients.
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
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2015 | Year | 06 | 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 | 01 | Month | 09 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014962
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| Registered date | File name |
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| Registered date | File name |
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