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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025742
Receipt No. R000029398
Scientific Title A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE)
Date of disclosure of the study information 2017/01/19
Last modified on 2017/01/19

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Basic information
Public title A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE)
Acronym A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE)
Scientific Title A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE)
Scientific Title:Acronym A phase III trial to confirm S-1 adjuvant chemotherapy for pathological stage II/III vulnerable elderly gastric cancer patients who underwent gastric resection (JCOG1507, BIRDIE)
Region
Japan

Condition
Condition Gastric neoplasm
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm superiority of S-1 with surgery alone in terms of overall survivall for vulnerable elderly patients who underwent D1+/D2 gastrectomy and were diagnosed pathologically with stage II/III gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Relapse-free survival, time-to-treatment-failure, proportion of treatment continuation, relative dose intensity, adverse events, severe adverse events

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: Surgery alone
Interventions/Control_2 B: Surgery followed by chemotherapy with S-1
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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric adenocarcinoma
2) Pathological stage II/III defined by 14th edition of Japanese Classification of Gastric Carcinoma
3) Received R0 gastrectomy with D1+ or D2 lymphadenectomy
4) 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
5) Either of the followings:
i) Weight loss < 15% and 30 mL/min <= Ccr for the patients received total gastrectomy
ii) Weight loss < 15% and 30 mL/min <= Ccr < 80 mL/min for the patients not received total gastrectomy
6) Within 5 to 7 weeks after surgery
7) Aged 80 years old or older
8) Performance status of 0 or 1
9) No gastric stump cancer
10) No previous treatment of chemotherapy, radiation therapy, or molecular-target therapy for any neoplasms. (History of hormone therapy more than one year ago is eligible.)
11) Enough oral intake
12) No dementia, or dementia with family support to continue protocol treatment or examinations
13) Sufficient organ functions
14) No ischemic change on ECG
15) Written informed consent
Key exclusion criteria 1) Synchronous double/multiple cancer or metachronous double/multiple cancer with progression free period of 5 years or shorter
2) Infectious disease requiring systemic treatment
3) Body temperature of 38 degrees Celsius or higher
4) Severe mental disease
5) Requiring systemic steroid medication (>= 5 mg/day of prednisolone)
6) Under treatment by flucytosine, phenytoin, or warfarin potassium
7) Uncontrolled diabetes mellitus
8) Uncontrolled hypertension
9) Unstable angina pectoris (angina developed or attack worsened within recent 3 weeks) or previous myocardial infarction within 6 months
10) Positive for HBs antigen
11) Severe interstitial pneumonia, severe lung fibrosis, or severe emphysema
12) Surgical morbidity such as infection, leakage, intestinal bleeding, pancreatic fistula, and so on is not improved
Target sample size 370

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Yoshida
Organization Gifu University Hospital, Gifu Municipal Hospital
Division name Department of Surgical Oncology
Zip code
Address 1-1 Yanagido, Gifu City 501-1194
TEL 058-230-6235
Email kyoshida@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Yamaguchi
Organization JCOG1507 Coordinating Office
Division name Gifu University Hospital, Gifu Municipal Hospital
Zip code
Address 1-1 Yanagido, Gifu City 501-1194
TEL 058-230-6235
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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)
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)
京都第2赤十字病院(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)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 19 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
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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 19 Day
Last follow-up date
2027 Year 07 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 19 Day
Last modified on
2017 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029398

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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