UMIN-CTR Clinical Trial

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
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007004