UMIN-CTR Clinical Trial

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