UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005366
Receipt number R000006291
Scientific Title A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.
Date of disclosure of the study information 2011/04/26
Last modified on 2018/01/04 09:50:45

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.

Acronym

A phase II study of trastuzumab added to docetaxel and S-1 for HER2-positive advanced gastric cancer.

Scientific Title

A phase II study of trastuzumab added to docetaxel and S-1 for human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer.

Scientific Title:Acronym

A phase II study of trastuzumab added to docetaxel and S-1 for HER2-positive advanced gastric cancer.

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and tolerability of trasuzumab added to S-1+docetaxel in HER2-positive advanced gastric cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

progression free survival

Key secondary outcomes

safety, objective response rate, overall survival, time to treatment failure


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

Intravenous infusion of trastuzumab (loading dose 8 mg/kg, 6 mg/kg) on day1, Intravenous administration of 40 mg/m2 docetaxel on Day 1, and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 every 3 weeks

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Pathological proven adenocarcinoma of inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach
2) HER2-positive tumors
3) Age 20-79 years
4) Measurable disease or non-measurable but assessable disease
5) No prior chemotherapy except for adjuvant chemotherapy with S-1
6) Adequate organ function
7) ECOG performance status<=2
8) Ejection fraction more than 50% by
ultrasound or MUGA
9) Expected more than 3 months survival
10) Sufficient oral intake
11) With written informed consent

Key exclusion criteria

1) with severe allergy to Trastuzumab, S-1 and docetaxel
2) Active infection or other inflammatory disease
3) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
4) Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, uncontrollable diabetes millutus, hypertension, and respiratory insufficiency.
5) History of cardiac disease
6) Dyspnea at rest, due to complications of advanced malignancy or other cardiovascular disease
7) Metastasis to CNS
8) Grade 3-4 peripheral sensory neuropathy
9) pregnant or nursing patient or with intent to bear baby
10) Inappropriate for the trial at the physician's assessment

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyoshi Fujiwara

Organization

Okayama University Graduate school of Medicine, Dentistry, and Pharmaceutical Sciences

Division name

Department of Gastroenterological Surgery

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

TEL

+81-86-235-7257

Email

toshi_f@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Kagawa

Organization

Okayama University Hospital

Division name

Department of Gastroenterological Surgery

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan

TEL

+81-86-235-7257

Homepage URL


Email

skagawa@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 26 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s00280-017-3505-4?wt_mc=Internal.Event.1.SEM.ArticleAuthor

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

2011 Year 03 Month 25 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 01 Day

Last follow-up date

2017 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2017 Year 12 Month 26 Day


Other

Other related information



Management information

Registered date

2011 Year 04 Month 01 Day

Last modified on

2018 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006291


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name