UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019544 |
|---|---|
| Receipt number | R000019623 |
| Scientific Title | Investigation of multimodality treatment for unresectable or recurrent gastric cancer |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2021/05/02 22:15:37 |
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Basic information
Public title
Investigation of multimodality treatment for unresectable or recurrent gastric cancer
Acronym
Investigation of multimodality treatment for unresectable or recurrent gastric cancer
Scientific Title
Investigation of multimodality treatment for unresectable or recurrent gastric cancer
Scientific Title:Acronym
Investigation of multimodality treatment for unresectable or recurrent gastric cancer
Region
| Japan |
Condition
Condition
unresectable or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the research is to clarify the meanings and timings of operation and radiotherapy for unresectable or recurrent gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Survival
Key secondary outcomes
Side effects of chemotherapy, perioperative complication
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
unresectable or recurrent gastric cancer
Key exclusion criteria
Patients with other malignant tumor with poorer survival.
Patients who decline the offer to use the data.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kakeji |
Organization
Kobe University
Division name
Division of Gastrointestinal Surgery
Zip code
6500017
Address
Kusunoki-chou 7-5-2, Chuo-ku, Kobe
TEL
078-382-5925
kakeji@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Suzuki |
Organization
Kobe University
Division name
Division of Gastrointestinal Surgery
Zip code
6500017
Address
Kusunoki-chou 7-5-2, Chuo-ku, Kobe
TEL
078-382-5925
Homepage URL
ss147@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Gastrointestinal Surgery
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
Kobe University
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-5014
rinri@med.kobe-u.ac.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
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.med.kobe-u.ac.jp/surg1/shinryou/igan.html
Publication of results
Published
Result
URL related to results and publications
https://ar.iiarjournals.org/content/38/4/2363.long
Number of participants that the trial has enrolled
127
Results
Multivariate analysis showed that gastrectomy,performance status 0/1, differentiated type, absence of distant organ metastasis, and second line chemotherapy was a prognostic factor. Among the patients with gastrectomy, R0 resection was a prognostic factor. R0 resection was mainly achieved when there was a single non-curable factor and no distant organ metastasis.
Results date posted
| 2021 | Year | 05 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unresectable gastric cancer
Participant flow
Patients were recruited retrospectively
Adverse events
none
Outcome measures
overall survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cohort study. Patients who were diagnosed as unresectable or recurrence of gastric cancer from 2015/11/1 to 2020/12/31 are calculated to this study.
The endpoints are as follows.
1. Treatment (chemotherapy only, chemotherapy after operation, operation after chemotherapy, with of without radiation therapy)
2. death investigation (date of death, cause of death)
3. selected chemotherapy and numbers of course
4. side-effects of chemotherapy according to the CTCAE guidelines.(RBC, Hb, WBC, Plt, TP, Alb, AST, ALT, gamma GTP, BUN, Cr)
5. timing of operation and operation method
6. operative complications according to the Clavien-Dindo classification.
Management information
Registered date
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019623
