UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis
Acronym	A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis
Scientific Title	A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis
Scientific Title:Acronym	A phase II study of systemic chemotherapy with S-1 and Oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of gastrectomy with D2 or D2 plus limited para-aortic lymph node dissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis following systemic chemotherapy with S-1 and Oxaliplatin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Phase II

Assessment
Primary outcomes	3-year overall survival
Key secondary outcomes	Proportion of R0 resection, 5-year overall survival, 3- and 5-year recurrence free survival, Proportion of completion of surgery, Proportion of completion of protocol treatment, Clinical response rate, Pathological response rate, Adverse events from chemotherapy, Operation time, Intraoperative blood loss, Surgical complications, Postoperative hospital stay

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	Gastrectomy with D2 or D2 plus dissection of para-aortic lymph nodes diagnosed as metastases at initial diagnosis is performed after three or four 21-day cycles of S-1 plus oxaliplatin. S-1 is also given for 1 year after gastrectomy.
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 adenocarcinoma 2) HER2 negative (IHC 0 or IHC 1+, or IHC 2+/FISH -) 3) One of the following conditions is fulfilled by enhanced CT 1. Paraaortic lymph node metastasis (No.16a2/ 16b1) 2. Bulky N (at least one node of 3 cm or more in diameter, or at least three consecutive nodes each of diameter 1.5 cm or more, along the coeliac, splenic, common or proper hepatic arteries or superior mesenteric vein.) 3. Both of No.16a2/ 16b1 and bulky lymph node metastasis 4. Thoracic/ abdominal/ pelvic enhanced CT reveals none of the following findings: i) Mediastinal lymph node metastasis ii) Lung metastasis iii) Peritoneal metastasis iv) Liver metastasis v) Pleural effusion, ascites beyond the pelvis vi) Paraaortic No. 16a1 or No. 16b2 swelling 1cm or greater vii) Other distant metastases (except for No. 13, No. 16a2 or No. 16b1 metastasis) 5) Neither Borrmann type 4 nor large (8cm or more) type 3 6) Length of esophageal invasion less than or equal to 3cm 7) Not stump cancer of stomach. 8) Clinically no sign of distant metastasis 9) No liver or peritoneal metastasis and CY0 by laparoscopy or laparotomy for bypass surgery within 28 days before registration 10) Age between 20 and 75 at registration 11) Performance Status (ECOG) 0 or 1 12) No prior chemotherapy, radiotherapy or endocrinotherapy 13) No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection 14) Fair oral intake with or without bypass surgery 15) Adequate organ functions defined as indicated below; i) WBC >= 4,000/mm3 and <= 12,000/mm3 ii) Neutrophils >= 4,000/mm3 iii) Hb >= 8.0 g/dl iv) Platelet >= 100,000/mm3 v) AST <= 100IU vi) ALT <= 100IU vii) T.bil <= 1.5 mg/dL viii) Creatinine <= 1.2 mg/dL viii) Ccr >= 60 mL/min/body 16) Written informed consent
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 oxaliplatin or S-1 9) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason 10) Edema of limbs or 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	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Sano
Organization	Cancer Institute Hospital
Division name	Division of gastroenterological surgery
Zip code
Address	3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL	03-3520-0111
Email	takeshi.sano@jfcr.or.jp

Public contact
Name of contact person	1st name Middle name Last name Koshi Kumagai
Organization	Cancer Institute Hospital
Division name	Division of gastroenterological surgery
Zip code
Address	3-8-31, Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL	03-3520-0111
Homepage URL
Email	koshi.kumagai@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital
Institute
Department

Funding Source
Organization	Self-sustaining fund
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	がん研究会有明病院（東京都） 国立がん研究センター中央病院（東京都） 静岡県立静岡がんセンター（静岡県） 国立がん研究センター東病院（千葉県） 愛知県がんセンター中央病院（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 01 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	Preinitiation
Date of protocol fixation	2017 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 26 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031497

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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