UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Acronym	Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Scientific Title	Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Scientific Title:Acronym	Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Region	Japan

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

Objectives
Narrative objectives1	CTC will be performed aiming at improvement of diagnostic performance in patients in whom peritoneal metastasis/recurrence of stomach cancer is suspected based on physical, laboratory test, and imaging findings, but no definite diagnosis can be made. The presence or absence of deformation suggesting peritoneal dissemination in the large intestinal wall will be diagnosed jointly by the physician in charge and radiologist and correlation with the clinical course will be analyzed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint of this study was the diagnostic sensitivity of CTC for PM. The secondary endpoints included overall survival (OS) and progression-free survival (PFS). Ideally, a pathological diagnosis is required to confirm PM; however, suspicious PM lesions detected by CTC are difficult to confirm using endoscopy or laparoscopy. Thus, we adopted the wait-and-see method to confirm PM. Patients were followed-up until the definitive development of PM. In this cohort study, the treatment to be administered after PM diagnosis was not specified. Accordingly, decisions regarding the timing of treatment initiation and the treatments to be administered were made on a case-by-case basis after a discussion between the patient and attending doctors. However, fluorouracil-compound plus cisplatin was administered as first-line chemotherapy when the patient did not undergo gastrectomy or developed recurrence, with the interval between S-1 adjuvant chemotherapy and recurrence being <6 months. All oncological definitions were in accordance with the Japanese Classification of Gastric Carcinoma 15th edition
Key secondary outcomes	The primary endpoint of this study was the diagnostic sensitivity of CTC for PM. The secondary endpoints included overall survival (OS) and progression-free survival (PFS). Ideally, a pathological diagnosis is required to confirm PM; however, suspicious PM lesions detected by CTC are difficult to confirm using endoscopy or laparoscopy. Thus, we adopted the wait-and-see method to confirm PM. Patients were followed-up until the definitive development of PM. In this cohort study, the treatment to be administered after PM diagnosis was not specified. Accordingly, decisions regarding the timing of treatment initiation and the treatments to be administered were made on a case-by-case basis after a discussion between the patient and attending doctors. However, fluorouracil-compound plus cisplatin was administered as first-line chemotherapy when the patient did not undergo gastrectomy or developed recurrence, with the interval between S-1 adjuvant chemotherapy and recurrence being <6 months. All oncological definitions were in accordance with the Japanese Classification of Gastric Carcinoma 15th edition

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	In this study, we aimed to use CTC for early detection of PM in patients in whom PM was suspected based on clinical symptoms and general CT findings but not yet diagnosed, and to administer anticancer agents in a timely and effective manner.
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	Inclusion criteria (i) histologically diagnosed gastric cancer via endoscopic biopsy or surgical specimen retrieval; (ii) suspected PM/recurrence of gastric cancer based on at least one of the following clinical findings: abnormal physical symptoms with causes that could not be explained by other diseases, elevation of serum tumor markers, and suspicious but not definitive signs of PM on conventional CT images; (iii) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; (iv) oral intake ability; and (v) provision of written consent by each patient.
Key exclusion criteria	Exclusion criteria were (i) inability to undergo bowel preparation; (ii) obvious intestinal stenosis; (iii) presence of massive ascites; and (iv) inability to undergo carbon dioxide (CO2) insufflation through the rectum.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Haruhiko Middle name Last name Cho
Organization	Kanagawa Cancer Center
Division name	Department of Gastrointestinal Surgery
Zip code	241-0815
Address	2-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, Japan
TEL	045-391-5761
Email	choharuhiko@kcch.jp

Public contact
Name of contact person	1st name Rika Middle name Last name Takahashi
Organization	Kanagawa Cancer Center
Division name	Department of Gastrointestinal Surgery
Zip code	241-0815
Address	2-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, Japan
TEL	045-391-5761
Homepage URL
Email	rika.takahasi@kcch.jp

Sponsor
Institute	Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Institute
Department

Funding Source
Organization	Department of Gastrointestinal Surgery, Kanagawa Cancer Center
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	Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Address	2-3-2 Nakao, Asahi Ward, Yokohama, Kanagawa, Japan
Tel	045-391-5761
Email	rika.takahasi@kcch.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	2021 Year 05 Month 11 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	18
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	No longer recruiting
Date of protocol fixation	2010 Year 06 Month 01 Day
Date of IRB	2010 Year 08 Month 01 Day
Anticipated trial start date	2010 Year 09 Month 20 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 05 Month 11 Day
Last modified on	2022 Year 05 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050436