UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007882
Receipt number R000009285
Scientific Title Multicenter double-blind randomized comparative parallel study with concomitant therapy of 3 drugs, aprepitant + dexamethasone+palonosetron or aprepitant + dexamethasone+ granisetron, for prevention of nausea/vomiting in breast cancer patients receiving AC therapy
Date of disclosure of the study information 2012/05/02
Last modified on 2016/06/07 12:35:28

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Basic information

Public title

Multicenter double-blind randomized comparative parallel study with concomitant therapy of 3 drugs, aprepitant + dexamethasone+palonosetron or aprepitant + dexamethasone+ granisetron, for prevention of nausea/vomiting in breast cancer patients receiving AC therapy

Acronym

Comparison of concomitant therapy with 3 drugs, aprepitant + dexamethasone+5HT3ra (palonosetron or granisetron), for prevention of nausea/vomiting in breast cancer patients receiving AC therapy;Trial for Antiemetic Triplet Therapy(TTT)

Scientific Title

Multicenter double-blind randomized comparative parallel study with concomitant therapy of 3 drugs, aprepitant + dexamethasone+palonosetron or aprepitant + dexamethasone+ granisetron, for prevention of nausea/vomiting in breast cancer patients receiving AC therapy

Scientific Title:Acronym

Comparison of concomitant therapy with 3 drugs, aprepitant + dexamethasone+5HT3ra (palonosetron or granisetron), for prevention of nausea/vomiting in breast cancer patients receiving AC therapy;Trial for Antiemetic Triplet Therapy(TTT)

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy of new antiemetic drugs (palonosetron) in AC therapy for breast cancer patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

The proportion of patients who showed complete response (no vomiting and no salvage treatment) during a period from 24 to 120 hours after AC therapy

Key secondary outcomes

(1)The proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 24 hours of AC therapy
(2)The proportion of patients who showed complete response (no vomiting and no salvage treatment) from 0 to 120 hours of AC therapy
(3)proportion of patients who showed no nausea / degree of nausea
(4)QOL
(5)Dietary intake
(6)Adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Aprepitant (day 1: 125 mg, days 2-3:80mg) + dexamethasone (day 1: 9.9 mg) + granisetron (day 1: 40(microgram)/kg)

Interventions/Control_2

Aprepitant (day 1: 125 mg, days 2-3:80mg) + dexamethasone (day 1: 9.9 mg) + palonosetron (day 1: 0.75 mg)

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

75 years-old >=

Gender

Female

Key inclusion criteria

1) Patients aged >= 20 years old and <= 75 years old (at the time informed consent was obtained)
2) Female patients
3) Patients with primary breast cancer of stages I to III who are scheduled to receive AC therapy
4) Patients with an ECOG Performance Status of 0 - 1
5) Patients who can correctly fill in a symptom diary
6) Patients who meet the following standard values in general clinical tests:
-White blood cells >= 3,000 /mm**3, and neutrophils >= 1,500 /mm**3
-Blood platelet count>= 100,000 /mm**3 -AST (GOT) and ALT (GPT) <= 2.5 times the high end of the normal range at the facility
-Total bilirubin <= 1.5 times the high end of the normal range at the facility
-Creatinine <= 1.5 times the high end of the normal range at the facility
7) Patients with normal cardiac function:
-ECG within the normal range, no symptoms, and no abnormality requiring treatment
- Cardiac function has been determinined to be normal by Interview, Echocardiography,Chest X-ray, BNP etc

Key exclusion criteria

1) Patients with a history of administration of moderate to high emetogenic chemotherapy
2) Patients receiving administration of an antiemetic drug (5-HT3 receptor antagonist, phenothiazine, butyrophenone, benzamide, or dopamine receptor antagonist)
3) Patients who received administration of a benzodiazepine or narcotic formulation within 48 hours before commencement of AC therapy
4) Patients who received systemic corticosteroid therapy within 72 hours before commencement of AC therapy
5) Patients with a history of gastrointestinal tract surgery (excluding appendectomy)
6) Patients who received or are scheduled to receive radiation therapy for the abdominal region (diaphragm or lower) or pelvis for a period from 6 days before commencement of AC therapy until Day 6 of AC therapy
7) Patients who had vomiting or dry vomiting within 24 hours before commencement of AC therapy
8) Patients with active multiple cancer (synchronous multiple cancer or metachronous multiple cancer with a disease-free interval of 5 years or less)
9) Patients with a symptomatic cerebral tumor (including a benign tumor)
10) Patients who received administration of the following drugs within 7 days before commencement of AC therapy: clarithromycin, erythromycin, ketoconazole, itraconazole, and digoxin
11) Patients who received administration of the following drugs within 4 weeks before commencement of AC therapy: barbiturate drug, rifampicin, phenytoin, and carbamazepine
12) Pregnant or lactating patients, patients who may be pregnant, patients hoping to become pregnant during the study period, and patients taking an oral contraceptive
13) Patients who have coexisting diseases, such as systemic infection, hepatitis, and uncontrollable diabetes, in whom dexamethasone sodium phosphate cannot be administered
14) Patients with a history of hypersensitivity to granisetron, palonosetron, aprepitant or dexamethasone
15) Other patients who are judged to be inappropriate for the study by the investigator.

Target sample size

660


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsue Saito

Organization

Juntendo University Hospital

Division name

Department of Breast Oncology

Zip code


Address

3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Email

mitsue@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsue Saito

Organization

Juntendo University Hospital

Division name

Department of Breast Oncology

Zip code


Address

3-1-3, Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Homepage URL


Email

mitsue@juntendo.ac.jp


Sponsor or person

Institute

Juntendo Clinical Research Support Center

Institute

Department

Personal name



Funding Source

Organization

Non-Profit Organization: Japan Clinical Research Support Unit

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Juntendo Nerima Hospital,Juntendo Urayasu Hospital,Juntendo Shizuoka Hospital,Shizuoka General Hospital,Mie University Hospital,Sapporo Medical University Hospital,Toho University Omori Medical Center,Ome Municipal General Hospital,Nippon Medical School Musashi Kosugi Hospital,Tottori University Hospital,Kanto Central Hospital of the Mutual Aid Association of Public School Teachers, Tokyo Medical University Hospital

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

順天堂大学医学部附属順天堂医院(東京),順天堂大学附属練馬病院(東京),順天堂大学附属浦安病院(千葉),順天堂大学附属静岡病院(静岡),静岡県立総合病院(静岡),三重大学医学部附属病院(三重),札幌医科大学附属病院(北海道),東邦大学医療センター大森病院(東京),青梅市立総合病院(東京),日本医科大学武蔵小杉病院(神奈川),鳥取大学医学部附属病院(鳥取),関東中央病院(東京),東京医科大学病院(東京)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 02 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

2011 Year 08 Month 30 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date

2015 Year 10 Month 31 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2015 Year 12 Month 24 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2012 Year 05 Month 02 Day

Last modified on

2016 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009285


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name