UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction(KSCC 1601)
Acronym	Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction(KSCC 1601)
Scientific Title	Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction(KSCC 1601)
Scientific Title:Acronym	Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction(KSCC 1601)
Region	Japan

Condition
Condition	Gastric cancer Esophagogastric junction cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Pathological response rate
Key secondary outcomes	Anastomotic leakage of tumours are classified as Siewert Type II and Type III Overall survival Complete resection rate, resection rate Relapse free survival Response rate Adverse events Surgical complecations

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
Interventions/Control_1	Oxaliplatin 130 mg/m2, IV day 1 , S-1 80-120 mg/m2/day, PO days 1-14, every 21 days for 3 cycles followed by surgery.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) The individual consents in writing to receipt of the protocol treatment 2) A lead investigator deems that the patient can be treated with the protocol (the patient is suitable for enrollment) 3) A common type of gastric adenocarcinoma (include Siewert Type III): T 3/4a/4b, N 1/2/3a/3b, esophagogastric junction adenocarcinoma classified as Siewert Type II: T 3/4a/4b, N 0/1/2/3a/3b 4) Enhanced thoracic/ abdominal/ pelvic CT revealed having none of the followings: i) Lung metastasis ii) Peritoneal metastasis iii) Liver metastasis iv) Pleural effusion, ascites v) Distal lymph nodes metastasis vi) Other distant metastasis 5) Clinically no sign of cervical lymph node nor distant metastasis 6) No liver metastasis and peritoneal metastasis, CY0 by laparoscopy 7) Not a remnant gastric cancer 8) No prior treatment of chemotherapy or radiation therapy or endocrine therapy against any other malignancies 9) No prior surgery for esophagogastric junction cancer and gastric cancer except for endoscopic resection 10) Age upon enrollment is over 20 years 11) Performance Status (ECOG) 0 or 1 12) The patient is readily able to take medication orally 13) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria i) WBC <=12,000/mm3 ii) Neutrophil >=1,500/mm3 iii) Platelet >=100,000/mm3 iv) Hemoglobin >=8.0g/dL v) Total bilirubin <=1.5mg/dL vi) AST,ALT <=100IU/L vii) Albumin >=2.5g/dL viii) Serum creatinine <=1.5mg/dL ix) Creatinine clearance >=60mL/min
Key exclusion criteria	1) Severe drug hypersensitivity (particularly to platinum analogs, 5-FU, or S-1) 2) Peripheral neuropathy affecting the sensory nerves (Grade 1 or worse) 3) Active infection 4) Uncontrollable hypertension 5) Uncontrollable diabetes mellitus or routine administration of insulin 6) Heart disease that may pose a problem 7) Severe pulmonary disease 8) Severe mental disease 9) Active gastrointestinal tract bleeding requiring repeated transfusions 10) Under treatment with phenytoin, warfarin or flucytosine 11) Watery diarrhea (Grade 2 or worse) 12) Synchronous or metachronous malignancies other than carcinoma in situ or mucosal cancer 13) A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner 14) Cirrhosis or hepatitis 15) Patients judged by the investigator as unfit to be enrolled in the study.
Target sample size	46

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Oki
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science, Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-631-2920
Email	sanae.sakamoto@ks-cc.or.jp

Public contact
Name of contact person	1st name KSCC Middle name Last name Research Secretariat
Organization	Clinical Research Support Center Kyushu
Division name	KSCC Research Secretariat
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-631-2920
Homepage URL
Email	sanae.sakamoto@ks-cc.or.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Certified Institutional Review Board for Clinical Trials
Address	3-1-1 Maidashi Higashi-ku Fukuoka, Fukuoka
Tel	092-642-5082
Email	byskenkyu@jimu.kyushu-u.ac.jp

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

国立病院機構九州医療センター（福岡県） 公立学校共済組合九州中央病院（福岡県） 済生会八幡総合病院（福岡県） 光晴会病院（長崎県） 熊本大学（熊本県） JCHO人吉医療センター（熊本県） 大分赤十字病院（大分県） 国立病院機構別府医療センター（大分県） 広島赤十字・原爆病院（広島県） 松山赤十字病院（愛媛県） 熊本地域医療センター（熊本県） 高知医療センター（高知県） 田川市立病院（福岡県） 慈泉会相澤病院（長野県） 薫風会佐野病院（兵庫県） 九州大学（福岡県） 国立病院機構九州がんセンター（福岡県） 製鉄記念八幡病院（福岡県） 国立病院機構福岡東医療センター（福岡県） 社会保険田川病院（福岡県） 久留米大学（福岡県） 長崎大学　移植・消化器外科，腫瘍外科（長崎県） 国立病院機構長崎医療センター（長崎県） 熊本赤十字病院（熊本県） 大分県立病院（大分県） 国立病院機構大分医療センター（大分県） 中津市中津市民病院（大分県） 鹿児島大学（鹿児島県） 鹿児島厚生連病院（鹿児島県） 飯塚病院（福岡県） 宗像医師会病院（福岡県） 神戸市立医療センター中央市民病院（兵庫県） 神戸大学（兵庫県） 香川大学（香川県） 公立八女総合病院（福岡県） 済生会唐津病院（佐賀県） 済生会川内病院（鹿児島県） 福岡市民病院（福岡県） 九州大学病院別府病院（大分県） 山口県立総合医療センター（山口県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 16 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	47
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	2016 Year 02 Month 16 Day
Date of IRB	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 16 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023935