UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031477 |
|---|---|
| Receipt number | R000035931 |
| Scientific Title | A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy |
| Date of disclosure of the study information | 2018/04/27 |
| Last modified on | 2019/03/26 10:34:30 |
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Basic information
Public title
A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy
Acronym
A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy
Scientific Title
A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy
Scientific Title:Acronym
A Phase II study of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy
Region
| Japan |
Condition
Condition
Advanced gastric cancer with with neoadjuvant chemotherapy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of laparoscopic gastrectomy for advanced gastric cancer with neoadjuvant chemotherapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Grade 3 or higher surgical complications (Clavien-Dindo Classification)
Key secondary outcomes
All surgical complications (Clavien-Dindo Classification), recurrence-free survival,over all survival, proportion of conversion to open surgery,number of retrieved lymph node, postoperative hospital stay, completion rate of adjuvant chemotherapy,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic gastrectomy
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)Histologically proven gastric carcinoma (including esophago-gastric junctional cancer)
(2)Prior treatment of chemotherapy for gastric cancer
(3)R0 resection or R1 resection solely by CY1 can be obtained
(4)Aged 20 to 79 years
(5) Eastern Cooperative Oncology Group (ECOG) PS of 0-2
(6) No obvious organ failures and satisfy the following laboratory data within 30 days before registration:
WBC >=2,000/mm3 WBC<15,000/mm3
Platelet >= 50,000/mm3
Hb >= 8.0 g/dL
AST <= local reference range 5
ALT <= local reference range 5
T.Bil <= 3.0 mg/dL
Creatinin <= 2.0 mg/dL
(7)Provided written informed consent
Key exclusion criteria
(1)Active infection disease
(2)Over 38.0 degree Celsius
(3)Severe mental disease.
(4)Continuous systemic steroid therapy.
(5)History of myocardial infarction or unstable angina pectoris within six months.
(6)Uncontrollable hypertension.
(7)Uncontrollable diabetes millutus or administration of insulin.
(8)Severe respiratory disease requiring continuous oxygen therapy.
(9)Kidney failure requiring hemodialysis or peritoneal dialysis
(10)Patients who are currently participating in an interventional study that strongly influences this study.
(11)Other unfeasible factors to perform study safely approved by attending surgeon.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukinori Kurokawa |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
ykurokawa@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Gakuhara |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
Homepage URL
agakuhara@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Osaka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Osaka University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 04 | Month | 27 | 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
| 2018 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035931
