UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040954 |
|---|---|
| Receipt number | R000046766 |
| Scientific Title | A prospective cohort study for evaluating the short-term outcomes of laparoscopic gastrectomy for advanced gastric cancer with preoperative chemotherapy |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2020/06/30 11:21:22 |
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Basic information
Public title
A prospective cohort study for evaluating the short-term outcomes of laparoscopic gastrectomy for advanced gastric cancer with preoperative chemotherapy
Acronym
A prospective cohort study of laparoscopic gastrectomy for advanced gastric cancer with preoperative chemotherapy
Scientific Title
A prospective cohort study for evaluating the short-term outcomes of laparoscopic gastrectomy for advanced gastric cancer with preoperative chemotherapy
Scientific Title:Acronym
A prospective cohort study of laparoscopic gastrectomy for advanced gastric cancer with preoperative chemotherapy
Region
| Japan |
Condition
Condition
Advanced gastric cancer with preoperative chemotherapy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the short-term outcomes of laparoscopic gastrectomy for advanced gastric cancer with preoperative chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of anastomotic leakage greater than Grade 2 and pancreatic fistula greater than Grade 3 according to Clavien-Dindo classification
Key secondary outcomes
1. Rate of curative resection (R0, R1), 2.
Overall survival, 3. Relapse-free survival, 4. Completion rate of laparoscopic surgery, 5. Rate of conversion to open surgery, 6. Intraoperative complications, 7. Postoperative complications, 8. Surgery-related death within 30 days, 9. In-hospital mortality, 10. Postoperative course, 11. Patterns of recurrence
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenocarcinoma
2) Clinical Stage III or Stage IV gastric cancer curably treated with total, proximal, or distal gastrectomy after preoperative chemotherapy
3) ECOG performance status of 0 or 1
4) Informed consent is obtained
Key exclusion criteria
1) With active double or multiple cancers
2) Severe complications
3) With active infection
4) Past history of severe hypersensitivity to drugs
5) Patients judged inappropriate for the study by the physicians
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Inomata |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1, Hasamamachi, Yufu City, Oita
TEL
097-586-5843
inomata@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Etoh |
Organization
Oita University Faculty of Medicine
Division name
Department of Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1, Hasamamachi, Yufu City, Oita
TEL
097-586-5843
Homepage URL
teto@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
General Clinical Research Center, Oita University Hospital
Address
1-1, Hasamamachi, Yufu City, Oita
Tel
097-586-6163
gcrc-oita@oita-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046766
