UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006069
Receipt number R000007004
Scientific Title A phase II study of systemic chemotherapy with Docetaxel, CDDP, and S-1 followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG1002, BulkyGC Pre-DCS Phase II)
Date of disclosure of the study information 2011/07/29
Last modified on 2022/08/30 16:06:55

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Basic information

Public title

A phase II study of systemic chemotherapy with Docetaxel, CDDP, and S-1 followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG1002, BulkyGC Pre-DCS Phase II)

Acronym

A phase II study of systemic chemotherapy with Docetaxel, CDDP, and S-1 followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG1002, BulkyGC Pre-DCS Phase II)

Scientific Title

A phase II study of systemic chemotherapy with Docetaxel, CDDP, and S-1 followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG1002, BulkyGC Pre-DCS Phase II)

Scientific Title:Acronym

A phase II study of systemic chemotherapy with Docetaxel, CDDP, and S-1 followed by surgery in advanced gastric cancer with extensive lymph node metastasis(JCOG1002, BulkyGC Pre-DCS Phase II)

Region

Japan


Condition

Condition

gastric neoplasm

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Docetaxel + CDDP + S-1 as preoperative chemotherapy for gastric cancer 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

response rate of preoperative chemotherapy by RECIST ver1.0

Key secondary outcomes

3-year survival, 5-year survival, proportion of R0 resection, proportion of completion of surgery, proportion of completion of protocol treatment, pathological 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 Docetaxel+CDDP+S-1 followed by gastrectomy with D2+No.16 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 primary gastric adenocarcinoma.
2) Enhanced abdominal CT revealed having any of the followings:
i) Paraaortic lymph node metastasis (No.16a2/ 16b1)
ii) Bulky lymph node (>=3cmx1 or >=1.5cmx2)
iii) Both of No.16a2/ 16b1 and Bulky lymph node
3) Enhanced thoracic/ abdominal/ pelvic CT revealed having none of the followings:
i) Mediastinal lymph node metastasis
ii) Lung metastasis
iii) Peritoneal metastasis
iv) liver metastasis
v) Pleural effusion, ascites
vi) Paraaortic No.16a1 or No.16b2 swelling 1cm or greater
vii) Other distant metastasis
4) Neither Borrmann type 4 nor large (8cm or more) type 3.
5) Length of esophageal invasion less or equal to 3cm.
6) Not stump cancer of stomach.
7) Clinically no sign of cervical lymph node nor distant metastasis.
8) No peritoneal metastasis and CY0 by laparoscopy or laparotomy.
9) Age between 20 and 75 at registration.
10) Performance Status(ECOG) 0 or 1.
11) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies.
12) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic resection.
13) Fair oral intake with or without bypass surgery.
14) Adequate organ functions defined as indicated below;
i) WBC >= 4,000/mm3 and <=12,000/mm3
ii) Neutrophil >= 2,000/mm3
iii) Hb >= 8.0 g/dL
iv) Platelet >= 100,000/mm3
v) AST <= 100 IU/L
vi) ALT <= 100 IU/L
vii) T.Bil <= 1.5 mg/dL
viii) Creatinin <= 1.5 mg/dL
ix) CCr >= 60mL/min/body
15) Written informed consent from patient."

Key exclusion criteria

"1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal cancer.
2) Women during pregnancy or breast-feeding.
3) Severe mental disease.
4) Under treatment with systemic steroid.
5) HBs antigen positive.
6) Under treatment with flucytosine, phenytoin, or warfarin.
7) Allergy to iodine.
8) History of hypersensitivity to DOC, CDDP, or polysorbate 80.
9) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason.
10) Edema of limbs and trunk by any reason.
11) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
12) Active bacterial or fungal infection.
13) Past history of myocardial infarction or unstable angina pectoris within 6 months.
14) Uncontrollable hypertension.
15) Uncontrollable diabetes mellitus or routine administration of insulin."

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Sano

Organization

Cancer Institute Hospital

Division name

GI Surgery Division

Zip code


Address

3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Seiji Ito

Organization

JCOG1002 Coordinating Office

Division name

Aichi Cancer Center Hospital, Department of Gastroenterological Surgery

Zip code


Address

1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan

TEL

052-762-6111

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

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

2011 Year 07 Month 29 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

Completed

Date of protocol fixation

2011 Year 06 Month 14 Day

Date of IRB

2011 Year 07 Month 04 Day

Anticipated trial start date

2011 Year 07 Month 01 Day

Last follow-up date

2019 Year 01 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

2011 Year 07 Month 29 Day

Last modified on

2022 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007004


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name