UMIN-CTR Clinical Trial

Public title

Optimal period of adjuvant S-1 chemotherapy for pathological stage II gastric cancer patients who underwent D2 gastrectomy(JCOG1104)

Acronym

Optimal period of adjuvant S-1 chemotherapy for pathological stage II gastric cancer patients who underwent D2 gastrectomy(JCOG1104, OPAS-1 phase III)

Scientific Title

Optimal period of adjuvant S-1 chemotherapy for pathological stage II gastric cancer patients who underwent D2 gastrectomy(JCOG1104)

Scientific Title:Acronym

Optimal period of adjuvant S-1 chemotherapy for pathological stage II gastric cancer patients who underwent D2 gastrectomy(JCOG1104, OPAS-1 phase III)

Region

Japan

Condition

gastric neoplasm

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To confirm non-inferiority of 4 courses of S-1 adjuvant chemotherapy with 8 courses of the same regimen in relapse-free survival in patients who underwent D1+/D2 gastrectomy and were diagnosed pathologically with stage II gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Relapse-free survival

Key secondary outcomes

Overall survival, Time-to-treatment-failure, adverse events, adverse events observed from 9 to 12 months after surgery, grade 4 non-hematological adverse events, early death, treatment-related death

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

arm A:8 courses of S-1 adjuvant chemotherapy

Interventions/Control_2

arm B:4 courses of S-1 adjuvant chemotherapy

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Gastric adenocaricinoma diagnosed pathologically (limited to the common type defined by the histological classification of the 14th edition of Japanese Classification of Gastric Carcinoma)
2) Pathological stage II defined by 14th edition of Japanese Classification of Gastric Carcinoma
3) Performance status of 0 or 1
4) Received R0 gastrectomy with lymph node dissection which fulfills either of the following conditions;
i) D1+ or D2 lymphadenectomy for clinical stage Ia,
ii) D2 lymphadenectomy for clinical stage Ib,
iii) Spleen-preserving total gastrectomy with modified D2 lymphadenectomy without nodal dissection of #10 or #10/#11d
5) Either of the following surgery performed;
i) Open laparotomy regardless of clinical stage and type of gastrectomy
ii) Laparoscopic or laparoscope-assisted distal, pylorus preserving, total or proximal gastrectomy for clinical stage I
6) Within 7 weeks after surgery
7) Age from 20 to 80 years old
8) No gastric stump cancer
9) No previous treatment of chemotherapy, radiation therapy, or molecular-targetting therapy for any neoplasms. (History of hormone therapy more than one year ago is eligible.)
10) Enough oral intake
11) Preserved organ function as follows;
i) neutrophile count >=1,200/mm3
ii) hemoglobin >=8.0 g/dL
iii) platelet count >=75,000/mm3
iv) AST=<100 IU/L
v) ALT=<100 IU/L
vi) total bilirubin =<2.0 mg/dL
vii) creatinine clearance (CCr) >=60 mL/min in case of body surface area >=1.25m2 or CCr >=40mL/min in case of body surface area < 1.25m2
12) Written informed consent

Key exclusion criteria

1)Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shoter, except for following;; prostate cancer with clinical stage I and completely resected following cancers; gastric cancer (adenocarcinoma) with stage 0-I, colon cancer (adenocarcinoma) with stage 0-I, esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma) with stage 0, breast cancer (noninvasive ductal carcinoma and noninvasive lobular carcinoma) with stage 0 and breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, and Paget disease) with stage 0-IIA, endometrial cancer (endometrioid adenocarcinoma and mucinous adenocarcinoma) with stage I, prostate cancer (adenocarcinoma) with stae I-II, cervical cancer (squamous cell carcinoma) with stage 0, thyroid cancer (papillary carcinoma and follicular carcinoma) with stage I-III, and renal cancer (clear cell carcinoma and chromophobe cell carcinoma) with stage I.
2) Infection requiring systemic treatment
3) Body temparature >=38c
4) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved
5) Women expecting pregnancy, in pregnancy, in possible pregnancy or in breast feeding
6) Male expecting partner's pregnancy
7) Severe mental disease
8) Under treatment by flucytosine, phenytoin, or warfarin potassium
9) Requiring systemic steroid medication (>= 5 mg/day of prednisolone)
10) Uncontrolled diabetes mellitus
11) Uncontrolled hypertension
12) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months
13) Positive for HBs antigen or HCV antibody
14) Interstitial pneumonia, lung fibrosis, or severe emphysema

Target sample size

1000

Name of lead principal investigator

1st name
Middle name
Last name	Masanori Terashima, M.D.

Organization

Shizuoka Cancer Center

Division name

Division of Gastric Surgery

Zip code

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, 411-8777, Japan

TEL

055-989-5222

Email

m.terashima@scchr.jp

Name of contact person

1st name
Middle name
Last name	Takaki Yoshikawa, M.D.

Organization

JCOG1104Coordinating Office

Division name

Department of Gastrointestinal Surgery, Kanagawa Cancer Center

Zip code

Address

2-3-2 Nakao, Asahi-Ku, Yokohama 241-8515, Japan

TEL

045-520-2202

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

函館厚生院函館五稜郭病院（北海道）
恵佑会札幌病院（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）
埼玉県立がんセンター（埼玉県）
埼玉医科大学国際医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（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）
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）
国立病院機構京都医療センター（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）
大阪府立病院機構大阪府立急性期・総合医療センター（大阪府）
大阪医科大学（大阪府）
市立豊中病院（大阪府）
堺市立総合医療センター（大阪府）
関西医科大学附属枚方病院（大阪府）
大阪労災病院（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）
岡山大学病院（岡山県）
広島大学病院（広島県）
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）
徳島赤十字病院（徳島県）
国立病院機構四国がんセンター（愛媛県）
大分大学医学部附属病院（大分県）

Date of disclosure of the study information

2012

Year

02

Month

16

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/30679107/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/30679107/

Number of participants that the trial has enrolled

590

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

Main results already published

Date of protocol fixation

2011

Year

12

Month

15

Day

Date of IRB

2012

Year

02

Month

10

Day

Anticipated trial start date

2012

Year

02

Month

16

Day

Last follow-up date

2027

Year

02

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

02

Month

16

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=R000008210