UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000009215
Receipt number	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	2022/11/07 18:25:48

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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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

cervical cancer, endometrial cancer, ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

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

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

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

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 or person

Institute

Sapporo medical university

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Completed

Date of protocol fixation

2012 Year 10 Month 27 Day

Date of IRB

2012 Year 10 Month 18 Day

Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

2014 Year 03 Month 31 Day

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

2022 Year 11 Month 07 Day

Link to view the page

Value
https://center6.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