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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012806
Receipt No. 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

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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
Obsterics 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
Email 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
Email kimi@med.kurume-u.ac.jp

Sponsor
Institute West Japan Gynecologic Oncology Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014962

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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