UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014251 |
|---|---|
| Receipt number | R000016568 |
| Scientific Title | Phase II trial of conversion surgery for unresectable gastric cancer |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2023/06/30 15:12:48 |
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Basic information
Public title
Phase II trial of conversion surgery for unresectable gastric cancer
Acronym
Conversion surgery for gastric cancer
Scientific Title
Phase II trial of conversion surgery for unresectable gastric cancer
Scientific Title:Acronym
Conversion surgery for gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of conversion surgery for unresectable gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
3 year survival rate
Key secondary outcomes
5 year survival rate, curative resection rate of conversion surgery, 3 year survival rate from conversion surgery, pathological response, adverse event
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
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed gastric cancer
2) Clinically diagnosed unresectable gastric cancer patients performed chemotherapy
3) No history of gastrectomy
4) Clinically diagnosed resectable after chemotherapy
5) Age between 20 and 80 at registration
6) Performance Status(ECOG) 0 or 1
7) Fair oral intake
8) Adequate organ functions
9) Written informed consent from patient
Key exclusion criteria
1) Synchronous other cancer
2) Female with present pregnancy or breast-feeding, or contemplating pregnancy
3) Mental disorders which may affect ability or willingness to provide informed consent of the study
4) Continuous systemic steroid therapy
5) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema
6) Active bacterial or fungal infection
7) Past history of myocardial infarction or unstable angina within 6 months
8) Uncontrollable hypertension
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Ito |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
464-8681
Address
1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL
0527626111
seito@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Seij |
| Middle name | |
| Last name | Ito |
Organization
Aichi Cancer Center Hospital
Division name
Department of Gastroenterological Surgery
Zip code
464-8681
Address
1-1 Kanokoden Chikuda-ku Nagoya Japan
TEL
0527626111
Homepage URL
seito@aichi-cc.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group (CCOG)
Institute
Department
Personal name
Funding Source
Organization
None
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
Aichi Cancer Center Institutional Review Board
Address
1-1 Kanokoden Chikuda-ku Nagoya Japan
Tel
052-762-6111
koutaku_kitano@aichi-cc.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
| 2014 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
Main results already published
Date of protocol fixation
| 2013 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016568
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
