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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000094
Receipt No. R000000142
Scientific Title A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)
Date of disclosure of the study information 2005/08/30
Last modified on 2014/06/24

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Basic information
Public title A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)
Acronym A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)
Scientific Title A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)
Scientific Title:Acronym A phase II study of systemic chemotherapy with TS-1 and CDDP followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG0405)
Region
Japan

Condition
Condition gastric neoplasm
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safty and efficacy of TS-1+CDDP as preoperative chemotherapy for gastric carcinoma in patients with extensive lymph node metastasis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Proportion of curative resection
Key secondary outcomes 3-year survival, proportion of completion of treatment, response rate, toxicities

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Preoperative chemotherapy with TS-1+CDDP followed by gastrectomy with D3 lymph node dissection
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric carcinoma
2) Macroscopic type 0, 1, 2, 3, 5
3) N3 (paraaortic) or bulky N2 metastases by CT
4) Thoracic/ abdominal/ pelvic enhanced CTrevealed none of the following:
i) Mediastinal lymph node metastais
ii) Cervical lymph node metastasis
iii) Lung metastasis
iv) Peritoneal metastasis, liver metastasis
v) Pleural effusion, ascites beyond the pelvis
vi) Paraaortic #16a1 or #16b2 swelling 1cm or greater
vii) Other distant metastasis
5) Esophageal invasion greater than 3cm by endoscopy or X-ray
6) Clinically no sign of distant metastasis
7) No peritoneal metastasis and CY0 by laparoscopy
8) Age between 20 and 75 at registration
9) Performance Status(ECOG) 0 or 1
10) No prior chemotherapy or radiotherapy
11) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection
12) Fair oral intake with or without bypass surgery
13) Blood test
i) WBC >= 3,000/mm3 and <= 12,000/mm3
ii) Hb >= 9.0 g/dl
iii) Platelet >= 100,000/mm3
iv) GOT <= 100IU
v) GPT <= 100IU
vi) T.bil <= 2.0 mg/dl
vii) Creatinin <= 1.5mg/dl
14) Renal function of either i) or ii)
i) Estimated Ccr >= 60ml/min/body
ii) Actual Ccr >= 60ml/min/body
15) Written informed consent
Key exclusion criteria 1) Active multiple cancer
2) Probable pregnancy, and the period of lactation
3) Difficulty to join the trial due to psychosis or psychotic symptoms
4) Under treatment with systemic steroid
5) Under treatment with flucytosine, phenytoin, or warfarin
6) Allergy to iodine
7) Serious complications
8) Past history of myocardial infarction withoin 6 months
9) Not fit to the protocol treatment by the physicion's dicision
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Sasako, MD, PhD
Organization Hyogo College of Medicine
Division name Upper GI Surgery Division
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Tsuburaya, MD
Organization JCOG0405 Coordinating Office
Division name Gastric Surgery Division, Kanagawa Cancer Center
Zip code
Address 1-1-2 Nakao, Asahi-ku, Yokohama, 241-0815, JAPAN
TEL
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)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
国立がんセンター中央病院(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)
癌研究会有明病院 (東京都)
都立墨東病院(東京都)
神奈川県立がんセンター(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総合病院(新潟県)
燕労災病院(新潟県)
富山県立中央病院(富山県)
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)
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)
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)
和歌山県立医科大学(和歌山県)
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)
国立病院機構四国がんセンター(愛媛県)
大分大学医学部附属病院 (大分県)

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24668391
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
2005 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2005 Year 02 Month 01 Day
Last follow-up date
2010 Year 06 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 08 Month 30 Day
Last modified on
2014 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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