UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007652 |
|---|---|
| Receipt number | 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 15:35:54 |
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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
Condition
Unresectable or recurrent gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
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
2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | 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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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
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
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 | 04 | Month | 03 | 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 | 08 | Month | 30 | 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 | 02 | Month | 14 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 03 | 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=R000008795
