UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	International Retrospective Cohort Study of Conversion Therapy (Adjuvant surgery) for Stage IV Gastric Cancer 1
Title of the study (Brief title)	International Retrospective Cohort Study of Conversion Therapy (Adjuvant surgery) for Stage IV Gastric Cancer 1 (CONVO-GC-1)
Region	Japan Asia(except Japan)

Condition
Condition	StageIV gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to clarify the present information of conversion therapy of stage IV gastric cancer in Asian counties, to investigate the feasibility of the therapy and to collect the baseline data for future analysis to clarify the role of the therapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of operative complications after conversion therapy
Key secondary outcomes	Overall Survival(OS), Relapse free survival(RFS), Response rate, and Histological response

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	To clarify the meaning of conversion therapy, we need to collect all stage IV gastric cancer patients who underwent operation with successful chemoradiationtherapy. 1. Histologically proven primary gastric adenocarcinoma. 2. Stage IV gastric cancer patients initially regarded as non-curably resectable but with successful chemotherapy, regarded as curably resectable (R0), then underwent radical operation (including metastasectomy). 3. Stage IV gastric cancer patients initially regarded as resectable, underwent radical operation after chemotherapy (neoadjuvant case). 4. Stage IV gastric cancer patients with peritoneal dissemination or positive cytology by staging laparoscopy or laparotomy but with successful chemotherapy, then underwent radical operation, or patients who underwent gastrectomy irrespective of chemotherapy.
Key exclusion criteria	None
Target sample size	900

Research contact person
Name of lead principal investigator	Kazuhiro YOSHIDA
Organization	Gifu University School of Medicine
Division name	Department of Surgical Oncology
Address	Yanagido 1-1, Gifu-city, Gifu
TEL	058-230-6235
Email	kyoshida@gifu-u.ac.jp

Public contact
Name of contact person	Mami SAKURAI
Organization	Federation of Asian Clinical Oncology (FACO)
Division name	Tokyo Office
Address	Shinkawa Bldg. 2F, 2-13-10, Shinkawa, Chu-ku, Tokyo 104-0033 Japan
TEL	03-5542-0546
Homepage URL
Email	faco-office@jsco.or.jp

Sponsor
Institute	FACO(Federation of Asian Clinical Oncology)
Institute
Department

Funding Source
Organization	FACO(Federation of Asian Clinical Oncology)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 05 Month 16 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 21 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Questionnaire survey (Retrospective cohort study) for patients completed adjuvant surgery from 01Jan2001 to 31Dec2014. Surveillance items of clinical data I. Sequence of diagnosis and treatment II. Patients' background information at diagnosis, Tumor status: Pathological diagnosis, Lauren classification, Depth of tumor, Lymph node metastasis, Liver metastasis, Peritoneal dissemination, Tumor diameter, Location of metastasis, Diagnostic staging laparoscopy, Diagnostic method for peritoneal dissemination, Other cancers, Complication and comorbidity, Having target lesion or not, HER2 status. III. Treatment status of chemotherapy and radiation therapy: Regimen, number of cycle, the reason of discontinuation, Dose and period of radiation therapy. IV. Evaluation of Response: Overall response evaluated by RECIST version 1.1. V. Surgical and Pathological Information: Type of tumor, Histological type, tumor diameter, Lymph node metastasis, number of metastasis and dissected lymph node, distant metastasis, Liver metastasis, Peritoneal dissemination, Peritoneal lavage cytology, Proximal and distal margin, Residual tumor, Reason for conversion therapy, Date of surgery, Operation time, Estimated blood loss, Volume of blood transfusion, mode of operation, Extension of lymph node dissection, Combined organ resection, Histological response. VI. Postoperative Complications: Wound infection, Thromboembolism, Anastomotic leakage, Intraperitoneal abscess, Pancraticfistula, Postoperative pneumonia, others. VII. Postoperative treatment status: Regimen of chemotherapy, number of cycle, Reason of discontinuation, dose and period of radiation therapy, Reason of no treatment. VIII. Confirmation of outcome: Date last known to be alive or date of death, Cause of death, Date of tumor relapse after curative resection, recurrent site, Survival status, Method of confirmation of outcome, Tumor relapse/recurrence.

Management information
Registered date	2016 Year 05 Month 16 Day
Last modified on	2018 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025719