UMIN-CTR Clinical Trial

Recruitment status	Completed
Unique ID issued by UMIN	UMIN000007652
Receipt No.	R000008795
Scientific Title	Phase III study of cisplatin plus S-1 (CS) compared with docetaxel and cisplatin plus S-1 (DCS) as first-line therapy for advanced gastric cancer(JCOG1013, GC_CS/DCS_P3 ADOPT)
Date of disclosure of the study information	2012/04/03
Last modified on	2022/08/30 (Ver. 11)

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Basic information

Public title

Phase III study of cisplatin plus S-1 (CS) compared with docetaxel and cisplatin plus S-1 (DCS) as first-line therapy for advanced gastric cancer(JCOG1013, GC_CS/DCS_P3 ADOPT)

Acronym

Adding docetaxel to cisplatin plus tegafur-gimeracil-oteracil for advanced gastric cancer(JCOG1013,GC_CS/DCS_P3 ADOPT)

Scientific Title

Phase III study of cisplatin plus S-1 (CS) compared with docetaxel and cisplatin plus S-1 (DCS) as first-line therapy for advanced gastric cancer(JCOG1013, GC_CS/DCS_P3 ADOPT)

Scientific Title:Acronym

Adding docetaxel to cisplatin plus tegafur-gimeracil-oteracil for advanced gastric cancer(JCOG1013,GC_CS/DCS_P3 ADOPT)

Region

Japan

Condition

Unresectable or recurrent gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

Objectives
Narrative objectives1	To demonstrate that docetaxel/ cisplatin/ S-1 therapy, DCS, is superior to cisplatin/ S-1 therapy, CS, in overall survival for patients with advanced gastric cancer and evaluate the difference of efficacy to DCS or CS between differntiated and undifferentiated adenocarcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Key secondary endpoint: overall survival in differentiated or undifferentiated adenocarcinoma Other secondary endpoints: progression free survival, response rate, dose intensity, adverse events, grade4 non-hematologic toxicity, early death, toxicity-related death, progression free survival and response rate in differentiated or undifferentiated adenocarcinoma

Base
Study type	Interventional

Study design
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

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: Oral S-1, 80 mg/m2 twice daily for 3 weeks followed by 2-week rest combined with intravenous cisplatin 60 mg/m2 given on day 8 every 5 weeks, until disease progression or unmanageable toxicity

Interventions/Control_2

B:Oral S-1, 80 mg/m2 twice daily for 2 weeks followed by 2-week rest combined with intravenous cisplatin 60 mg/m2 and docetaxel 40 mg/m2 given on day 1 every 4 weeks, until disease progression or unmanageable toxicity

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

years-old

Age-upper limit

years-old

Gender

Male and Female

Key inclusion criteria

1) Histological confirmed adenocarcinoma; papillary, tubular, poorly, signet ring cell, mucinous, or hepatoid
2) unresectable advanced or recurrent gastric cancer
3) No massive ascites
4) No evidence of central nervous system metastasis
5) Measurable or non-measurable disease
6) Able to eat or drink
7) Aged >20 and <75
8) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
9) HER2 negative, or unknown at registration
10) No previous chemotherapy, radiotherapy, or hormone therapy except post-operative adjuvant chemotherapy with S-1 alone as long as it was completed at least 24 weeks prior to randomization, or either pre- or post-operative adjuvant chemotherapy with platinum, which includes cisplatin plus S-1, oxaliplatin plus S-1, or oxaliplatin plus capecitabine, with less than 180 mg/m2 of a total dose of cisplatin or 1040 mg/m2 of oxaliplatin, as long as it was completed at least 24 weeks prior to randomization
11) Adequate organ function:
i) Neutrophil >1,500/mm3
ii) Platelet >100,000/mm3
iii) Total bilirubin <1.5 mg/dL
iv) AST<100 IU/L(<200 IU/L in patients with liver metastasis)
v) ALT<100 IU/L(<200 IU/L in patients with liver metastasis)
vi) Serum creatinine<1.5 mg/dL
12)Written informed consent

Key exclusion criteria

1) Multiple primary cancers with disease-free period less than 5 years, except carcinoma in situ or intra mucosal disease cured by local therapy
2) Active infection
3) Fever more than 38c
4) Pregnant, unwilling to practice contraception during the study, or lactating female
5) Uncontrolled psychiatry disease
6) Chronic daily treatment with oral or intravenous corticosteroids
7) Uncontrolled diabetes mellitus or chronic daily treatment with insulin
8) Unstable angina, or past history of myocardial infarction in 6 months
9) Evidence of any other serious disease; renal failure, hepatic failure, interstitial pneumonitis or lung fibrosis
10) Active bleeding
11) Massive pleural effusion, more than half of thoracic space at least one-side

Target sample size

740

Research contact person

Name of lead principal investigator

1st name	Yasuhide
Middle name
Last name	Yamada

Organization

National Cancer Center Hospital

Division name

Department of gastrointestinal onclolgy

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan

TEL

03-3542-2511

Email

yayamada@ncc.go.jp

Public contact

Name of contact person

1st name	Yasuhide
Middle name
Last name	Yamada

Organization

JCOG1013 Coordinating Office

Division name

National Cancer Center Hospital

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.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

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）
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）
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）
岡山大学病院（岡山県）
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

2012

Year

Month

Day

Related information
URL releasing protocol	This protocol is not open to the public. Please refer to the link below for the results posted.
Publication of results	Published

Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/31101534/

Number of participants that the trial has enrolled

741

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

Results date posted

2022

Year

Month

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Please refer to the "clinical study report" posted on the following website.
http://www.jcog.jp/basic/clinicaltrial/index.html

Participant flow

Please refer to the "clinical study report" posted on the following website.
http://www.jcog.jp/basic/clinicaltrial/index.html

Adverse events

Please refer to the "clinical study report" posted on the following website.
http://www.jcog.jp/basic/clinicaltrial/index.html

Outcome measures

Please refer to the "clinical study report" posted on the following website.
http://www.jcog.jp/basic/clinicaltrial/index.html

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2012

Year

Month

Day

Date of IRB

2012

Year

Month

Day

Anticipated trial start date

2012

Year

Month

Day

Last follow-up date

2018

Year

Month

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2018

Year

Month

Day

Other
Other related information

Management information

Registered date

2012

Year

Month

Day

Last modified on

2022

Year

Month

Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008795