UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002801 |
|---|---|
| Receipt number | R000003174 |
| Scientific Title | Study on Efficacy and Safety of Continuous Chemotherapy or Conversion Surgery after Downstaging of Non-curative Factors by Chemotherapy for Initially Unresectable Advanced Gastric Cancer |
| Date of disclosure of the study information | 2009/11/27 |
| Last modified on | 2013/12/26 12:06:04 |
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Basic information
Public title
Study on Efficacy and Safety of Continuous Chemotherapy or Conversion Surgery after Downstaging of Non-curative Factors by Chemotherapy for Initially Unresectable Advanced Gastric Cancer
Acronym
Treatment after downstaging of non-curative factors by chemotherapy for gastric cancer
Scientific Title
Study on Efficacy and Safety of Continuous Chemotherapy or Conversion Surgery after Downstaging of Non-curative Factors by Chemotherapy for Initially Unresectable Advanced Gastric Cancer
Scientific Title:Acronym
Treatment after downstaging of non-curative factors by chemotherapy for gastric cancer
Region
| Japan |
Condition
Condition
Inoperable advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of conversion surgery for advanced gastric cancer after downstaging of non-curative factors by chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
proportion of curative resection, proportion of pathological response, adverse event, overall survival
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed gastric cancer
2) Patients who have non-curative factors before chemotherapy and were diagnosed all the factors disappeared after chemotherapy
3) Age over 20 at registration
4) ECOG PS 0 to 1
5) Excluding for remnant gastric cancer
6) No history of gastrectomy
7) Tolerable for surgery with sufficient organ functions
8) Written informed consent for patients who need follow-up
Key exclusion criteria
1) Serious comorbidities
2) Synchronous other cancer or metachronous other cancer within 5 years from onset, excluding curable early cancers with local treatment
3) Current inflammation or acute inflammatory disease
4) Female with present pregnancy or breast-feeding, or contemplating pregnancy. Male disagreeing with birth control
5) Mental disorders which may affect ability or willingness to provide informed consent of the study
6) History of severe drug allergy
7) Patients judged inappropriate for the study by the physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Cho |
Organization
Kanagawa cancer center
Division name
gastrointestinal surgery
Zip code
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
TEL
045-520-2222
choharuhiko@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Cho |
Organization
Kanagawa cancer center
Division name
gastrointestinal surgery
Zip code
Address
2-3-2, Nakao, Asahi-ku, Yokohama, Kanagawa
TEL
045-520-2222
Homepage URL
choharuhiko@kcch.jp
Sponsor or person
Institute
Kanagawa cancer center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa standard anti-cancer therapy support system (KSATSS)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 11 | Month | 27 | 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
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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of prognosis between conversion surgery group and continuous chemotherapy group
Management information
Registered date
| 2009 | Year | 11 | Month | 26 | Day |
Last modified on
| 2013 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003174
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
