UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007368
Receipt number R000008675
Scientific Title Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old
Date of disclosure of the study information 2012/02/23
Last modified on 2018/03/08 08:46:31

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Basic information

Public title

Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old

Acronym

JACCRO GC-06

Scientific Title

Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old

Scientific Title:Acronym

JACCRO GC-06

Region

Japan


Condition

Condition

HER2-positive advanced gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation ofr the efficacy and safety of S-1 plus trastuzumab for elderly (more than 65 years old) HER2-positive advanced gastric cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate (RR)

Key secondary outcomes

Overall survival(OS)
Progression free survaval(PFS)
Time to treatment faulure(TTF)
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

Drug:TS-1 and Trastuzumab
TS-1:80mg/m2/dat on Day 1-28
Trastuzumab:6mg/kg/body on Day 1 and Day 22 (first time: 8mg/kg/body)

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction.
2) Patients who have measurable region defined by RECIST version 1.1.
3) Patients who have HER2-positive cancer confirmed with IHC and /or FISH (IHC 3+ or IHC2+ and FISH positive)
4) More than 65 years old.
5) Performance status (ECOG scale) 0, 1 or 2.
6) No prior chemotherapy or radiotherapy for gastric cancer.
7) Adequate baseline organ and marrow function as defined below:
1. Leukocyte : 3,500-12,000/mm3
2. Absolute neutrophil count : >= 2,000/mm3
3. Platelets : >= 100,000/mm3
4. Hemoglobin : >=9.0g/dL
5. AST : < 100IU/L
6. ALT : < 100IU/L
7. Total bilirubin : < 1.5mg/dL
8. Serum creatinine : <= 1.2mg/dL
9. Creatinine clearance : >= 50ml/min
8) Patients with left ventricular ejection fraction of at leaset 50% on MUGA scan or echocardiography done within 21days before enrollment.
9) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment
10) Patients able to take orally
11)Life expectancy of greater than 3 months
12) Patients should sign a written informed consent.

Key exclusion criteria

1) Scond primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence)
2) Severe ascites and / or pleural effusion
3) Patients with brain metastasis
4) Patients with fresh bleeding from gastric cancer and / or the digestive tract
5) Patients with active infection (> 38C)
6) Patients have active hepatitis type B
7) Patients with a previous history of congestive heart failure
8) Unstable angina requiring medication
9) Patients with a previous history of transmural infarct
10) Uncontrolled hypertension
11) Severe heart valve diseases
12) Hi-risk uncontrolled arrhythmias
13) Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus
14) Patients with resting dyspnea
15) Patients with diarrhea (4 or more times per day or watery diarrhea) 16) Patients who are contraindicated to TS-1 and Trastuzumab
17) Hypersensitivity to have a history TS-1 and / or Trastuzumab
18) Patients who are received systemic continuous admnistration of flucytosine.
19) Patients who are recieving systemic continuous administration of phenytoin or warfarin
20) Patients who are received systemic administration of corticosteroid for a long time or with high doses
21) Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. Men who want their partners to become pregnant.
22) Any patinets judged by the investigator to be unfit to perticipate in the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroya Takiuchi

Organization

Osaka Medical College

Division name

Cancer Chemotherapy Center

Zip code


Address

2-7 Daigaku-cho, Takatsuki, Osaka, 569-8181

TEL

03-3293-1711

Email

masashi.fujii@gioncology.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Fujii

Organization

Japan Clinical Cancer Research Organization

Division name

Secretariat

Zip code


Address

1-14-5 Ginza, Chuo-ku, Tokyo

TEL

03-5579-9882

Homepage URL


Email

gc06.dc@jaccro.or.jp


Sponsor or person

Institute

Japna Clinical Cancer Research Organizetion

Institute

Department

Personal name



Funding Source

Organization

Taiho Pharmaceutical Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

大阪医科大学附属病院(大阪府)ほか、JACCRO参加施設


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 12 Month 13 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2016 Year 02 Month 01 Day

Date of closure to data entry

2016 Year 02 Month 28 Day

Date trial data considered complete

2016 Year 09 Month 01 Day

Date analysis concluded

2016 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 23 Day

Last modified on

2018 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008675


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name