UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026783 |
|---|---|
| Receipt number | R000030711 |
| Scientific Title | A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis |
| Date of disclosure of the study information | 2017/05/01 |
| Last modified on | 2023/04/04 09:45:30 |
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Basic information
Public title
A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis
Acronym
A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis
Scientific Title
A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis
Scientific Title:Acronym
A feasibility study of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of neoadjuvant chemotherapy with docetaxel+cisplatin+capecitabine (DCX) for HER2-negative gastric cancer with macroscopic type 4 and large type 3, or with multiple lymph node metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events
Key secondary outcomes
Overall survival
Progression-free survival
Proportion of patients with gastrectomy
Proportion of patients with R0 resection
Pahological response rate
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
Capecitabine 2000mg/m2/day days 1-14
Cisplatin 60mg/m2 day1
Docetaxel 30mg/m2 day1
every 3 weeks
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Gastric adenocarcinoma. HER2 IHC- or IHC1+, or IHC2+/FISH-
2) At least either of the following:
1. large type 3 (>=8cm)
2. type 4
3. Bulky N (at least one node of 3 cm or more in diameter, or at least three consecutive nodes each of diameter 1.5 cm or more, along the coeliac, splenic, common or proper hepatic arteries or superior mesenteric vein.)
3) ECOG PS 0-1
4) No previous chemothrapy or radiation therapy
5) Laboratory data
1.WBC>=3,000/mimcrol
2.Neutrophil>=1,500/microl
3.Hemoglobin>=8.0 g/dL
4.Platelet>=100,000/microl
5.Total bilirubin<=1.5 mg/dL
6.AST(GOT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
7.ALT(GPT)<=ULNx2.5(<=ULNx5 if presence of liver metastasis)
8.Serum creatinine<=1.3 mg/dL
9.Creatinine clearance>=60 mL/min
10.Ejection fraction on echo cardiogram>=50%
Key exclusion criteria
1) HER2 IHC 3+, or IHC 2 and FISH+
2) Uncontrolled diabetes
3) Uncontrolled hypertension
4) Unstable angina pectoris, or a history of myocardial infarction within six months
5) Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema
6) Synchronous cancers (except for cases whose prognositc facter is gastric cancer)
7) Systemic infection requiring treatment
8) Fever above 38 degree Celsius
9) A possibility of pregnancy or during pregnancy, or lactating women
10) Psychosis or psychotic symptoms
11) Continuous systemic administration of steroids (oral or intravenous)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Maeda |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
maeda-o@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Maeda |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
Homepage URL
maeda-o@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030711
