UMIN-CTR Clinical Trial

Public title

An exploratory study on genomic profiling predicting chemotherapy resistance for advanced gastric cancer

Acronym

TROX Study-A1

Scientific Title

An exploratory study on genomic profiling predicting chemotherapy resistance for advanced gastric cancer

Scientific Title:Acronym

TROX Study-A1

Region

Japan

Condition

Gastric Cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To explore genomic profiling which influences on efficacy and tolerability of chemotherapy with trastuzumab biosimilar for advanced or recurrent gastric cancer patients using targeted 435-gene next generation sequencing panel (CANCRPLEX-JP). This study is being conducted as an ancillary study of TROX study.

Basic objectives2

Others

Basic objectives -Others

To evaluate the feasibility of NGS analysis for the evaluation of HER2 status before treatment.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

An exploratory analysis of genome information which correlate with efficacy and adverse event of trastuzumab biosimilar treatment for gastric cancer using NGS-based 435 gene panel testing of specimen before treatment.

Key secondary outcomes

To evaluate the feasibility of NGS analysis for the evaluation of HER2 status before treatment.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Male and Female

Key inclusion criteria

1)The individual consents in writing to receipt of the protocol treatment
2)A lead investigator deems that the patient can be treated with the protocol
3)The cancer is histopathologically confirmed to be a common type of gastric cancer
4)Up to 28 days prior to enrollment, contrast-enhanced CT scans of the trunk confirm that 1 or more target lesions is present according to RECIST v1.1
5)The primary tumor or a metastatic focus is determined to be HER2-positive
6)The patient has not previously received chemotherapy, immunotherapy, or radiation therapy
7)When a patient has advanced/recurrent gastric cancer not amenable to curative surgery
8)When palliative surgery or non-curative resection is performed, two weeks should be passed at least after operation and any postoperative complications should be improved.
9)The patient's age upon enrollment is over 20 and under 80 years
10)The patient has a PS of 0 or 1 on the ECOG Scale
11)The patient is readily able to take medication orally
12)The patient is fully expected to survive for 3 months or longer from the day of enrollment
13)The patient has no severe dysfunction of major organs and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
i) WBC count<=12,000/mm^3
ii) Neutrophil count>=1,500/mm^3
iii) Platelet count>=100,000/mm^3
iv) Hemoglobin>=8.0g/dL
v) Total bilirubin<=1.5mg/dL
vi) AST*<=100IU/L
vii) ALT*<=100IU/L
*200 IU/L or lower when liver metastasis is noted
viii) Albumin>=2.5g/dL
ix) Serum creatinine<=1.5mg/dL
x) Creatinine clearance>=60mL/min
14)The patient has a left ventricular ejection fraction of 50% or more according to echocardiography or a multiple-gated acquisition scan performed up to 14 days prior to enrollment

Key exclusion criteria

1)A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment
2)The patient has severe drug hypersensitivity
3)The patient has peripheral neuropathy affecting the sensory nerves
4)The patient has an active infection
5)The patient has poorly controlled hypertension
6)The patient has poorly controlled diabetes
7)If a 12-lead ECG reveals marked ECG abnormalities up to 14 days prior to enrollment or the patient has heart disease that may pose a problem
8)The patient has severe pulmonary disease
9)The patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction
10)The patient has active gastrointestinal tract bleeding requiring repeated transfusions
11)The patient is receiving phenytoin, warfarin potassium, or flucytosine
12)The patient has moderate or more severe fluid accumulation in body cavities, such as pleural effusions and ascites, that continually requires treatment such as drainage
13)The patient has brain metastasis or clinical features suggesting brain metastasis
14)The patient has extensive bone metastasis
15)The patient has watery diarrhea
16)The patient has active multiple cancers
17)The patient has a history of receiving platinum-based antineoplastic agents
18)A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner
19)The patient tests positive for HBsAg or antibodies to HCV
20)A patient who is deemed to need antiviral therapy for HBV-related hepatitis
21)A lead investigator or the patient's primary physician otherwise deems that participation in this trial is not appropriate for the patient

Target sample size

120

Name of lead principal investigator

1st name	Yuichiro
Middle name
Last name	Nakashima

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Science

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan

TEL

092-642-5466

Email

yuicnakashima@gmail.com

Name of contact person

1st name	Sanae
Middle name
Last name	Sakamoto

Organization

Kyushu Study group of Clinical Cancer

Division name

KSCC Research Secretariat

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan

TEL

092-409-3500

Homepage URL

Email

sanae.sakamoto@ks-cc.or.jp

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name

Organization

Denka Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyushu University Certified Institutional Review Board for Cli nical Trials

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan

Tel

092-642-5082

Email

byskenkyu@jimu.kyushu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院

Date of disclosure of the study information

2019

Year

05

Month

28

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

2019

Year

01

Month

18

Day

Date of IRB

2019

Year

04

Month

08

Day

Anticipated trial start date

2019

Year

05

Month

16

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Feasibility of NGS analysis for the evaluation of HER2 positive
Concordance of analysis result of HER2 amplification positive between IHC or FISH methods and NGS-based panel testing.

Registered date

2019

Year

05

Month

28

Day

Last modified on

2019

Year

05

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041899