UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044167
Receipt number R000050436
Scientific Title Feasibility study of CT colonography for peritoneal metastasis of gastric cancer clinically difficult to diagnose definitely
Date of disclosure of the study information 2021/05/11
Last modified on 2022/05/13 05:55:17

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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 or person

Institute

Department of Gastrointestinal Surgery, Kanagawa Cancer Center

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050436


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name