UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002801
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email choharuhiko@kcch.jp

Sponsor
Institute Kanagawa cancer center
Institute
Department

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
Email

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
URL(English) https://upload.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


Contact us.