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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009215
Receipt No. R000010820
Scientific Title Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial
Date of disclosure of the study information 2012/11/01
Last modified on 2012/11/12

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Basic information
Public title Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial
Acronym Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial
Scientific Title Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial
Scientific Title:Acronym Palonosetron in combination with 1-day versus 3-day dexamethason for prevention of nausea and vomiting following paclitaxel and carboplatin for gynecologic cancer: a randomized, multicenter, phase 2 trial
Region
Japan

Condition
Condition cervical cancer, endometrial cancer, ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed CINV following paclitaxel and carboplatin regimen
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of patients with complete response (no vomiting and no rescue medication use) during the 120 hours observation period after the infusion of chemotherapy.
Key secondary outcomes (1) Complete response rate during acute phase (0-24hr) and delayed phase (24-120hr). (2)Complete control rate during acute phase (0-24hr) and delayed phase (24-120hr).
(3) Adverse events defined on CTCAE ver 4.0

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Palonosetoron + dexamethasone day 1-3
Interventions/Control_2 Palonosetoron + 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

Not applicable
Gender Female
Key inclusion criteria 1)Patients of age =>20
2)Diagnosis of cervical cancer, endometrial cancer, ovarian cancer
3)No history of systemic chemotherapy
4)receiving carboplatin and paclitaxel (TC) chemotherapy. The following treatment is planned.
Conventional TC: Paclitaxel 175mg/m2 (day1) + Carboplatin AUC6 (day1)
Dose dense TC: Paclitaxel 80mg/m2 (day1, 8, 15) + Carboplatin AUC6 (day1)
5)Adequate bone-marrow function, renal function, liver function
6)Performance status: 0-1 (ECOG)
7)Written informed consent
Key exclusion criteria They had serious complication.
No known CNS metastasis
Patients who has a convulsive disorders that need anticonvulsants therapy
They had ascites or pleural effusion needs paracentesis treatment
Patients with obstruction of gastrointestinal tract,for example gastric outlet or ileus
Patients with vomiting or nausea (>= Grade2)
Hypersensitivity or severe drug allergy for 5-HT3RA
Hypersensitivity or severe drug allergy for dexamethasone
Pregnant, breastfeeding or expecting woman
Patients with a history of palonosetron
Without the capability or the intention of cooperating
Participated in other anti-emetic clinical trial
Patients judged inappropriate for this study by physicians
Target sample size 110

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Saito
Organization Sapporo Medical University
Division name Gynecology
Zip code
Address South1, West16, Sapporo, Japan
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Motoki Matsuura
Organization Nikko Memorial Hospital
Division name Gynecology
Zip code
Address
TEL
Homepage URL
Email motoki.gyne@gmail.com

Sponsor
Institute Sapporo medical university
Institute
Department

Funding Source
Organization none
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
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
2012 Year 11 Month 01 Day

Related information
URL releasing protocol
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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 29 Day
Last modified on
2012 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010820

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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