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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036865
Receipt No. R000041899
Scientific Title An exploratory study on genomic profiling predicting chemotherapy resistance for advanced gastric cancer
Date of disclosure of the study information 2019/05/28
Last modified on 2019/05/28

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Basic information
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
Condition Gastric Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
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

Assessment
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.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Denka Company Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 28 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
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
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.

Management information
Registered date
2019 Year 05 Month 28 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041899

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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