UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000001012
Receipt No. R000001177
Scientific Title A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor (JCOG0705/KGCA01)
Date of disclosure of the study information 2008/02/04
Last modified on 2022/08/30 (Ver. 12)

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Basic information
Public title A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor (JCOG0705/KGCA01)
Acronym A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor (JCOG0705/KGCA01)
Scientific Title A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor (JCOG0705/KGCA01)
Scientific Title:Acronym A randomized controlled trial comparing gastrectomy plus chemotherapy with chemotherapy alone in advanced gastric cancer with a single non-curable factor (JCOG0705/KGCA01)
Region
Japan Asia(except Japan)

Condition
Condition clinical stage IV gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the survival benefit and safety of gastrectomy plus chemotherapy compared to chemotherapy alone in clinical stage IV gastric cancer with a single non-curable factor
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes progression-free survival, adverse events

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
Medicine Maneuver
Interventions/Control_1 A: Chemotherapy alone (S-1 80mg/m2 on days 1-21; CDDP 60mg/m2 on day 8, every 5 weeks)
Interventions/Control_2 B: Gastrectomy with D1 lymphadenectomy followed by chemotherapy (S-1 80mg/m2 on days 1-21; CDDP 60mg/m2 on day 8, every 5 weeks)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven primary gastric adenocarcinoma.
2) Presence of distant metastases confined to either liver (H1), peritoneum (P1), or para-aortic lymphnode (16a1/b2), which is confirmed by both CT scan and laparotomy.
3) Clinical T1-3.
4) No other distant metastasis than H1, P1or M1(LN 16a1/b2).
5) No apparent pleural effusion.
6) Length of esophageal invasion 3cm or less with no need of thoracotomy for resection.
7) Aged 20 to 75 years old.
8) PS of 0 or 1.
9) Sufficient oral intake without active bleeding from the gastric tumor.
10) No prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer except EMR.
11) Adequate organ functions defined as indicated below
(1)WBC >= 3,000 /mm3 , WBC <= 12,000 /mm3
(2)Hb >= 8.0 g/dL without any transfusion 2 weeks before enrollment
(3)Plt >= 100,000 /mm3
(4)AST <= 100 IU/L
(5)ALT <= 100 IU/L
(6)T.Bil <= 2.0 mg/dL
(7)Cr <= 1.2 mg/dL
(8)Ccr >= 60 mL/min/body
12) Written informed consent
Key exclusion criteria 1) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
2) Women during pregnancy or breast-feeding.
3) Psychosis.
4) Systemic steroids medication.
5) Medication of furucytocin, fenytoin, or warfarin.
6) Active bacterial infection or mycosis, affecting systemic condition.
7) Myocardial infarction or unstable angina, occurred within 6 months.
8) Uncontrollable hypertension.
9) Uncontrollable diabetes mellitus or administration of insulin.
10) Pulmonary disease necessitating continuous oxygen supply.
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimasa Tsujinaka
Organization National Hospital Organization Osaka National Hospital
Division name Department of Surgery
Zip code
Address 2-1-14, Hoenzaka, Chuo-ku, Osaka, Osaka 540-0006, Japan
TEL 06-6942-1331
Email JCOG_sir@ml.jcog.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Fujitani
Organization JCOG0705 Coordinating Office
Division name National Hospital Organization Osaka National Hospital, Department of Surgery
Zip code
Address 2-1-14, Hoenzaka, Chuo-ku, Osaka, Osaka 540-0006, Japan
TEL 06-6942-1331
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

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
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 函館厚生院函館五稜郭病院（北海道）
岩手医科大学 （岩手県）
国立病院機構仙台医療センター（宮城県）
宮城県立がんセンター （宮城県）
山形県立中央病院 （山形県）
栃木県立がんセンター（栃木県）
防衛医科大学校 （埼玉県）
埼玉県立がんセンター（埼玉県）
国立がん研究センター東病院（千葉県）
国立がん研究センター中央病院 （東京都）
がん・感染症センター都立駒込病院 （東京都）
東京医科歯科大学 （東京都）
がん研究会有明病院 （東京都）
虎の門病院（東京都）
都立墨東病院 （東京都）
神奈川県立病院機構神奈川県立がんセンター （神奈川県）
北里大学医学部（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
新潟県立がんセンター新潟病院 （新潟県）
新潟県厚生連長岡中央綜合病院 （新潟県）
燕労災病院 （新潟県）
富山県立中央病院 （富山県）
石川県立中央病院（石川県）
岐阜大学医学部（岐阜県）
岐阜市民病院 （岐阜県）
静岡県立総合病院 （静岡県）
静岡県立静岡がんセンター（静岡県）
愛知県がんセンター中央病院 （愛知県）
名古屋大学医学部（愛知県）
藤田保健衛生大学 （愛知県）
国立病院機構京都医療センター（京都府）
京都第2赤十字病院 （京都府）
大阪大学医学部（大阪府）
近畿大学医学部 （大阪府）
大阪府立病院機構大阪府立成人病センター （大阪府）
国立病院機構大阪医療センター （大阪府）
大阪医科大学 （大阪府）
市立豊中病院 （大阪府）
市立堺病院 （大阪府）
関西医科大学附属枚方病院（大阪府）
神戸大学医学部（兵庫県）
関西労災病院（兵庫県）
兵庫医科大学（兵庫県）
兵庫県立がんセンター（兵庫県）
市立伊丹病院 （兵庫県）
天理よろづ相談所病院（奈良県）
和歌山県立医科大学 （和歌山県）
島根大学医学部（島根県）
広島市立広島市民病院 （広島県）
広島市立安佐市民病院（広島県）
福山市民病院（広島県）
国立病院機構四国がんセンター（愛媛県）
高知医療センター（高知県）
大分大学医学部附属病院（大分県）

Other administrative information
Date of disclosure of the study information
2008 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26822397
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
2007 Year 12 Month 18 Day
Date of IRB
2008 Year 02 Month 01 Day
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2014 Year 02 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
2008 Year 02 Month 04 Day
Last modified on
2022 Year 08 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001177