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
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
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
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
