UMIN-CTR Clinical Trial

Public title

A randomized phase II study investigating an optimal dosing regimen of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer

Acronym

Phase II study of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer

Scientific Title

A randomized phase II study investigating an optimal dosing regimen of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer

Scientific Title:Acronym

Phase II study of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer

Region

Japan

Condition

Unresectable and/or recurrent gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Study of an optimal dosing regimen of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A
TS-1 80 mg/m2, day 1-21, CDDP 60 mg/m2, day 8.
The above doses are repeated every 35 days.
Trastuzumab 8 mg/kg, day 1 (6 mg/kg after the second administration)
The above dose is repeated every 21days.

Interventions/Control_2

Group B
TS-1 80 mg/m2, day 1-14, CDDP 60 mg/m2, day 1.
The above doses are repeated every 21 days.
Trastuzumab 8 mg/kg, day 1 (6 mg/kg after the second administration)
The above dose is repeated every 21 days.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Subjects with radically unresectable or recurrent gastric cancer
2) Subjects whose HER2 status in primary or metastatic lesions has already been proven
3) Subjects with measurable lesions according to RECIST v1.1 within 28 days before enrollment
4) Subjects without pretreatment (radiation therapy, chemotherapy, hormone therapy, etc.) for gastric cancer
(Subjects with an elapsed time longer than 24 weeks after completion of the most recent preoperative chemotherapy or postoperative adjuvant chemotherapy can be enrolled.)
5) Subjects at least 20 years but not more than 75 years of age at the time of enrollment
6) Performance Status:Subjects with an ECOG PS score of 0 or 1
7) Subjects capable of oral ingestion
8) Subjects proven to have well-maintained functions of the following main organs (bone marrow, heart, lungs, kidneys, etc.) by examinations within 14 days before enrollment (Examinations on the same day two weeks before enrollment are allowed.)
White blood cell count: more than 3,500/mm3, less than 12,000/mm3
Neutrophil count : more than 2,000/mm3
Hemoglobin: more than 9.0 g/dL
Platelet count: more than 100,000/mm3
Total bilirubin: less than 1.5 mg/dL
AST, ALT: less than 100 IU/L
Creatinine: less than 1.2 mg/dL
Creatinine clearance: more than 60 ml/min
9) Subjects with LVEF values exceeding 50% on cardiac function examinations such as echocardiography within 28 days before enrollment
10) Subjects without clinically important abnormalities on 12-lead electrocardiography within 28 days before enrollment
11) Subjects with an expected survival time of at least three months after the date of enrollment
12) Subjects providing written informed consent to participate in the study

Key exclusion criteria

1)Subjects with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.)
2)Subjects with a previous history of serious drug hypersensitivity
3)Subjects requiring continuous use of flucytosine, phenytoin, and/or warfarin potassium
4)Subjects being treated with pyrimidine fluoride antineoplastic agents other than TS-1(including any combination therapy)
5)Subjects with infectious diseases associated with a fever of 38.0 degrees C or higher
6)Subjects shown to be HBs antigen positive
7)Subjects with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, cardiac failure, bone-marrow suppression, and so on)
8)Subjects with diarrhea (more than four times daily or watery stool)
9)Subjects with accumulation of pleural and ascitic fluids requiring paracentesis for symptom relief
10)Subjects with the following cardiac diseases or conditions
Previous history of congestive cardiac failure
Angina pectoris requiring drug treatment
Obvious transmural myocardial infarction on electrocardiograph
Clinically-evident cardiac valvular disease
Poorly-controlled hypertension (systolic BP>180mmHg and/or diastolic BP>100mmHg)
High-risk uncontrolled arrhythmias
A previous history of myocardial infarction
Ischemic cardiac disease requiring treatment
11)Women of child-bearing potential (intention), pregnant or lactating women
12)Men desiring to have children
13)Subjects with a previous history of serious psychiatric diseases or being treated for such diseases and judged to be ineligible for participating in the study
14)Subjects judged by the investigator(s) to be inappropriate study participants for any other reason

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Sumio Watanabe

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

3-1-3 Hongo Bunkyo-ku Tokyo

TEL

03-3813-3111

Email

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

TEL

03-3813-3111

Homepage URL

Email

Institute

Juntendo University School of Medicine
Department of Gastroenterology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2012

Year

06

Month

25

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

Open public recruiting

Date of protocol fixation

2012

Year

06

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

25

Day

Last modified on

2012

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009727