UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000122 |
|---|---|
| Receipt number | R000000180 |
| Scientific Title | Randomized controlled trial to evaluate surgical approaches to gastric cancer invading the esophagus (JCOG9502) |
| Date of disclosure of the study information | 2005/09/07 |
| Last modified on | 2014/02/21 14:17:29 |
* 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
Randomized controlled trial to evaluate surgical approaches to gastric cancer invading the esophagus (JCOG9502)
Acronym
Randomized controlled trial to evaluate surgical approaches to gastric cancer invading the esophagus (JCOG9502)
Scientific Title
Randomized controlled trial to evaluate surgical approaches to gastric cancer invading the esophagus (JCOG9502)
Scientific Title:Acronym
Randomized controlled trial to evaluate surgical approaches to gastric cancer invading the esophagus (JCOG9502)
Region
| Japan |
Condition
Condition
gastric neoplasm
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
relapse-free survival, operative morbidigy and mortality, quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A: Surgery: abdominal and transhiatal approach
Interventions/Control_2
B: Surgery: left thoraco-abdominal approach
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) histologically proven adenocarcinoma
(2) 75 years old or younger
(3) forced expiratory volume in one second ≥ 50 %
(4) arterial oxygen pressure in room air ≥ 70 mmHg
(5) clinically T2/T3/T4 with ≤3 cm esophageal invasion
(6) written consent
Key exclusion criteria
(1) Carcinoma in the remnant stomach
(2) Borrmann type 4 (linitis plastica)
(3) synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
(4) history of left thoracotomy, or left pleural adhesion
(5) past history of myocardial infarction or positive results of exercise ECG
(6) liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%
Target sample size
265
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Sasako, MD |
Organization
Hyogo College of Medicine
Division name
Upper GI Surgery Division
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, 663-8501, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Sasako, MD |
Organization
JCOG9502 Coordinating Office
Division name
Upper GI Surgery Division, Hyogo College of Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, 663-8501, JAPAN
TEL
Homepage URL
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00149266
Org. issuing International ID_1
ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/16887481
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html
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
Completed
Date of protocol fixation
| 1995 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 1995 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 07 | Day |
Last modified on
| 2014 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000180
