UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010460
Receipt number R000012224
Scientific Title A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.
Date of disclosure of the study information 2013/04/10
Last modified on 2016/10/19 22:23:21

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Basic information

Public title

A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.

Acronym

A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.

Scientific Title

A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.

Scientific Title:Acronym

A phase II trial of combination therapy with palonosetron / dexamethasone or palonosetron / aprepitant / dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients with urothelial cancer.

Region

Japan


Condition

Condition

urothelial cancer

Classification by specialty

Hematology and clinical oncology Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of combination therapy with palonosetron / dexamethasone (in moderately emetic CINV) or palonosetron / aprepitant / dexamethasone (in high emetic CINV) in patients with urothelial cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Complete response rate during 120 hours (all phase) after a platinum agent dosage start

Key secondary outcomes

1. Complete response rate during 0 to 24 hours (acute phase) and 24 to 120 hours (delay phase ) after a platinum agent dosage start
2. Complete control rate during acute phase and delay phase and all phase after a platinum agent dosage start
3. Grade of nausea during acute phase and delay phase and all phase after a platinum agent dosage start
4. Safety


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

Moderately emetic chemotherapy
Palonosetron
0.75mg iv. prior to a platinum agent dosage start

Dexamethasone
9.9mg iv. prior to a platinum agent dosage start
8mg po. day2-4

High emetic chemotherapy
Palonosetron
0.75mg iv. prior to a platinum agent dosage start

Dexamethasone
9.9mg iv. prior to a platinum agent dosage start
8mg po. day2-4

Aprepitant
125mg po. prior to a platinum agent dosage start
80mg po. day2, 3
or
Fosaprepitant
150mg iv. prior to a platinum agent dosage start

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

Male and Female

Key inclusion criteria

1. The patient who plans the medication of the following anticancer agents as urothelial cancer chemotherapy
Moderately emetic chemotherapy-GN therapy
High emetic chemotherapy-MVAC or GC therapy
2. The patient whom an anticancer agent is not given to or an anticancer agent of low emetic risk has been given to in the past
3. Age at the time of the registration is a patient 20 years or older
4. Adequate organ function
5. ECOG performance status of 0 or 1
6. Given written informed consent

Key exclusion criteria

1. Receiving pimozide (MVAC or GC therapy)
2. With other sever diseases
3. Clinical suspicion or history of metastasis to brain or meninges
4. Patients who need anticonvulsants therapy
5. Ascites and/or pleural effusion to need treatment
6. Pyloric stenosis and/or intestinal obstruction
7. Vomiting, or grade 2 or higher nausea according to CTCAE ver4.0
8. History of drug allergy
9. Pregnant or lactating women or women of childbearing potential, and no birth-control
10. Patient who doesn't have ability or intention that cooperates for procedure of the study
11. Not appropriate for the study at the physician's assessment

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinobu Kubota

Organization

Yokohama city university graduate school of medicine

Division name

Department of urology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2679

Email

nakaigan@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noboru Nakaigawa

Organization

Yokohama city university graduate school of medicine

Division name

Department of urology

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan

TEL

045-787-2679

Homepage URL


Email

nakaigan@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama city university

Institute

Department

Personal name



Funding Source

Organization

none

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

大口東総合病院
小田原市民病院
神奈川県立足柄上病院
神奈川県立がんセンター
神奈川リハビリテーション病院
川崎市立井田病院
国際親善病院
国立病院機構相模原病院
済生会横浜市南部病院
茅ヶ崎市民病院
東芝林間病院
秦野赤十字病院
平塚共済病院
藤沢市民病院
藤沢湘南台病院
大和市立病院
横浜栄共済病院
横浜市立市民病院
横浜市立大学附属市民総合医療センター
横浜市立大学附属病院
横浜みなと赤十字病院
横浜南共済病院
横須賀共済病院


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 10 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

2013 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 05 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

2013 Year 04 Month 10 Day

Last modified on

2016 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012224


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name