UMIN-CTR Clinical Trial

Public title

Efficacy and safety of a triple antiemetic combination with palonosetron, dexamethasone and aprepitant in patients receiving multiple-day cisplatin-containing chemotherapy.

Acronym

Efficacy and safety of a triple antiemetic combination in patients receiving multiple-day cisplatin-containing chemotherapy.

Scientific Title

Efficacy and safety of a triple antiemetic combination with palonosetron, dexamethasone and aprepitant in patients receiving multiple-day cisplatin-containing chemotherapy.

Scientific Title:Acronym

Efficacy and safety of a triple antiemetic combination in patients receiving multiple-day cisplatin-containing chemotherapy.

Region

Japan

Condition

germ cell tumors

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy by complete response (no vomiting and no rescue medication) during the overall period (Days 1-9) and safety of the antiemetic therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

The proportion of patients with complete response (no vomiting and no rescue medication) during Days 1-9.

Key secondary outcomes

(1) The proportion of patients with CR in acute phase (Days 1-5) or delayed phase (Days 6-9).
(2) Incidence and severity of nausea in the overall period, acute phase or delayed phase.
(3) The proportion of patients receiving rescue medication.
(4) The proportion of patients developing adverse drug reactions.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

palonosetron 0.75 mg, iv (Day 1)
dexamethasone 9.9 mg, iv (Day 1)
dexamethasone 6.6 mg, iv (Days 2-8)
aprepitant 125 mg, oral (Day 1)
aprepitant 80mg, oral (Days 2-5)

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients diagnosed as germ cell tumor histologically and/or serologically.
(2) Patients scheduled to receive 5-day fractionated chemotherapy with cisplatin in hospitalization.
(3) 20 years old or older at time of registration.
(4) ECOG PS of patients is 0-2.
(5) Patients can fill a questionnaire appropriately.
(6) Patients will provide written informed consent.

Key exclusion criteria

(1) Patients have primary or secondary brain and/or intestinal cancer.
(2) History of hypersensitivity to any drugs included in the protocol therapy.
(3) Patients developing vomiting or retching within 24 hours prior to beginning chemotherapy.
(4) Patients receiving antiemetic agents including benzodiazepines within 48 hours prior to beginning chemotherapy.
(5) Patients during treatment with pimozide.
(6) Patients receiving at least one drug in the following drugs : macrolide antibiotics, azole antifungal agents, barbiturates, warfarin, phenytoin, diltiazem, midazolam, tolbutamide, hormonal contraceptives, HIV protease inhibitors.
(7) Patients considered to be ineligible for this study by physicians.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Koji Kawakami

Organization

Graduate School of Medicine and Public Health, Kyoto University

Division name

Department of Pharmacoepidemiology

Zip code

Address

Yoshidakonoecho, Sakyo-ku, Kyoto, Japan 606-8501

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine and Public Health, Kyoto University

Division name

Department of Pharmacoepidemiology

Zip code

Address

TEL

075-753-9469

Homepage URL

Email

Institute

Graduate School of Medicine and Public Health, Kyoto University

Institute

Department

Personal name

Organization

Graduate School of Medicine and Public Health, Kyoto University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

25

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

03

Month

24

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2014

Year

03

Month

04

Day

Other related information

Registered date

2011

Year

04

Month

25

Day

Last modified on

2014

Year

07

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006530