UMIN-CTR Clinical Trial

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

Gastric cancer
Esophagogastric junction cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name

Organization

Yakult Honsha Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

02

Month

16

Day

Last modified on

2021

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023935