UMIN-CTR Clinical Trial

Public title

A phase II trial of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting for gynecological cancer.

Acronym

KCOG-G1301

Scientific Title

A phase II trial of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting for gynecological cancer.

Scientific Title:Acronym

KCOG-G1301

Region

Japan

Condition

gynecological cancer

Classification by specialty

Hematology and clinical oncology

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to investigate the efficacy and the safety of the combined use of aprepitant, palonosetron, dexamethasone and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in gynecological cancer patients receiving cisplatin-based (cisplatin >= 50 mg/m2) chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

The percentage of patients with complete response (no emetic episodes and no use of rescue medication) for the overall period (0~120h post-administration of cisplatin).

Key secondary outcomes

(1) The percentage of patients with complete response for the acute period (0~24h post-administration of cisplatin) and the delayed period (24~120h post-administration of cisplatin).
(2) The percentage of patients with complete control (no emetic episodes, no use of rescue medication, and no more than mild nausea defined as nausea visual analogue scale 0~2) for the acute period, the delayed period, and the overall period.
(3) The percentage of patients with total control (no emetic episodes, no use of rescue medication, and no nausea defined as nausea visual analogue scale 0) for the acute period, the delayed period, and the overall period.
(4) Adverse events.

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

1) Aprepitant 125 mg is administered orally 60~90 minutes before cisplatin administration. Post-chemotherapy, patients receive oral aprepitant 80 mg on days 2 and 3. If fosaprepitant is used instead of aprepitant, fosaprepitant 150 mg is administered intravenously 60~90 minutes before cisplatin administration.
2) Palonosetron 0.75 mg is administered intravenously 30~60 minutes before cisplatin administration.
3) Dexamethasone 9.9 mg is administered intravenously (or 12 mg orally) 30~60 minutes before cisplatin administration. Postchemotherapy, patients receive dexamethasone 6.6mg intravenously (or 8mg orally) on days 2~4.
4) Patients receive oral olanzapine 5mg before day of chemotherapy (day -1) and continued 5 mg daily for days 1~5 before retiring.

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

80

years-old

>

Gender

Female

Key inclusion criteria

1. Chemotherapy-naive patients of gynecological cancer.
2. Patients who receive cisplatin-based chemotherapy (cisplatin >= 50 mg/m2).
3. ECOG performance status (PS) 0~2.
4. Patients who have signed informed consent.
5. Patients who are 20 years old or older and younger than 80 years old at the enrollment.

Key exclusion criteria

1. Patients who had received chemotherapy previously.
2. Patients who are operated radiation therapy concurrently.
3. HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1. FBS >= 126mg/dl or BS >= 200mg/dl.
4. Patient with nausea and vomiting need for medical treatment on the day before chemotherapy.
5. Patients who take antipsychotic drug.
6. Patient who have familial history of syndrome malin.
7. BMI (body mass index) >= 35.
8. Child-pugh score > 9.
9. Patient who take pimozide.
10. AST, ALT more than 2.5 times of institutional upper normal limit. Bilirubin more than 2 times of institutional upper normal limit.
11. CK (CPK) more than 2.5 times of institutional upper normal limit.
12. Serum creatinine more than 1.5 times of institutional upper normal limit.
13. Patients with active infection.
14. Patients with ascites and/or pleural effusion which needs treatment and resistant to treatment.
15. Patients who have conceived child or desire childbearing or breast-feed their baby.
16. Patient who cannot stop smoking during this study.
17. Patients who enrolled other clinical trial within 90 days before the enrollment of this study.
18. Patients who are decided to be ineligible for this study by the principal investigator.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Masakazu Abe

Organization

Shizuoka Cancer Center

Division name

Division of Gynecology

Zip code

Address

1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka

TEL

055-989-5222

Email

ma.abe@scchr.jp

Name of contact person

1st name
Middle name
Last name	Masakazu Abe

Organization

Shizuoka Cancer Center

Division name

Division of Gynecology

Zip code

Address

1007, Shimonagakubo, Nagaizumicho, Suntogun, Shizuoka

TEL

055-989-5222

Homepage URL

Email

ma.abe@scchr.jp

Institute

Kansai Clinical Oncology Group (KCOG)

Institute

Department

Personal name

Organization

none

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

静岡県立静岡がんセンター（静岡県）、関西労災病院（兵庫県）、兵庫医科大学付属病院（兵庫県）、奈良医大付属病院（奈良県）、奈良県立奈良病院（奈良県）、三重大学付属病院（三重県）、大分大学付属病院（大分県）、名古屋市立大学付属病院（愛知県）、東京女子医大東病院（東京都）、富山大学付属病院（富山県）、岐阜大学付属病院（岐阜県）、京都府立医科大学（京都府）、滋賀医科大学付属病院（滋賀県）、聖隷浜松病院（静岡県）

Date of disclosure of the study information

2013

Year

09

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

2013

Year

09

Month

18

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

25

Day

Last modified on

2015

Year

03

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013858