UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000094
Receipt number 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 16:13:22

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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 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


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

Value
https://center6.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