UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036865 |
|---|---|
| Receipt number | 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 00:28:26 |
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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
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
sanae.sakamoto@ks-cc.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041899
