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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040954
Receipt No. 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

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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
Email 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
Email teto@oita-u.ac.jp

Sponsor
Institute Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046766

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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