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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017552
Receipt No. R000019474
Scientific Title A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501B) examining oxaliplatin + S-1 + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy
Date of disclosure of the study information 2015/05/29
Last modified on 2019/01/06

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Basic information
Public title A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501B) examining oxaliplatin + S-1 + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy
Acronym A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501B) examining oxaliplatin + S-1 + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy
Scientific Title A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501B) examining oxaliplatin + S-1 + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy
Scientific Title:Acronym A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501B) examining oxaliplatin + S-1 + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of oxaliplatin + S-1 (SOX) + trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy.
* To examine the efficacy and safety of SOX for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy in trial KSCC 1501A.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response proportion (RECISTv1.1)
Key secondary outcomes Safety profile*1, progression-free survival (PFS) , overall survival (OS), time-to-treatment failure (TTF), Duration of treatment , time to failure of strategy (TFS) , dose intensity
*1 Particular attention will be paid to thrombocytopenia, peripheral sensory neuropathy, and allergic reactions.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A course of treatment lasts 21 days, and treatment will be continued until any of the criteria for discontinuation of the protocol treatment are met. On day 1, oxaliplatin 130 mg/m2 and trastuzumab 8 mg/kg (reduced to 6 mg/kg in the second round and afterwards) will be administered intravenously. In accordance with body surface area, S-1 40-60 mg will be given orally twice a day, once after breakfast and once after dinner, for 14 consecutive days (starting at dinner on day 1 and given until breakfast on day 15) , followed by a 7-day rest period (starting S-1 after breakfast on day 1 or after breakfast on day 2 is not permitted).
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
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
3)The cancer is histopathologically confirmed (via resected surgical specimens biopsied tissue) to be a common type of gastric cancer (adenocarcinoma)
4)Up to 28 days prior to enrollment, contrast-enhanced CT scans of the trunk (chest,upper abdomen,and pelvis) confirm that 1 or more target lesions is present according to RECIST v1.1
5)The primary tumor or a metastatic focus is determined to be HER2-positive
6)The patient has not previously received chemotherapy, immunotherapy, or radiation therapy
7)When a patient has advanced/recurrent gastric cancer not amenable to curative surgery
8)When palliative surgery or non-curative resection is performed, two weeks should be passed at least after operation and any postoperative complications should be improved. (Laparoscopic examination is excluded from this criterion.)
9)The patient&#39;s age upon enrollment is over 20 and under 80 years
10)The patient has a PS of 0 or 1 on the ECOG Scale
11)The patient is readily able to take medication orally
12)The patient is fully expected to survive for 3 months or longer from the day of enrollment
13)The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient&#39;s laboratory results from up to 14 days prior to enrollment fall within the criteria
i)WBC count <=12,000/mm3
ii)Neutrophil coun t>=1,500/mm3
iii)Platelet count >=100,000/mm3
iv)Hemoglobin >=8.0g/dL
v)Total bilirubin <=1.5mg/dL
vi) AST,ALT <=100IU/L
*200 IU/L or lower when liver metastasis is noted
vii)Albumin >=2.5g/dL
viii)Serum creatinine <=1.5mg/dL
ix)Creatinine clearance >=60mL/min
14)The patient has a left ventricular ejection fraction (LVEF) of 50% or more according to echocardiography or a multiple-gated acquisition (MUGA) scan performed up to 14 days prior to enrollment
Key exclusion criteria 1)A patient who has received a transfusion, blood product, or hematopoietic growth factor such as G-CSF up to 14 days prior to enrollment
2)The patient has severe drug hypersensitivity (particularly to platinum analogs,5-FU,S-1,or trastuzumab)
3)The patient has peripheral neuropathy affecting the sensory nerves (Grade 1 or worse)
4)The patient has an active infection
5)The patient has poorly controlled hypertension
6)The patient has poorly controlled diabetes
7)If a 12-lead ECG reveals marked ECG abnormalities up to 14 days prior to enrollment or the patient has heart disease that may pose a problem
8)The patient has severe pulmonary disease
9)he patient has a psychiatric disorder that may pose a problem or a history of central nervous system dysfunction
10)The patient has active gastrointestinal tract bleeding requiring repeated transfusions
11)The patient is receiving phenytoin, warfarin potassium,or flucytosine
12)The patient has moderate or more severe fluid accumulation in body cavities,such as pleural effusions and ascites,that continually requires treatment such as drainage
13)The patient has brain metastasis or clinical features suggesting brain metastasis
14)The patient has extensive bone metastasis (as determined by the patient&#39;s primary physician)
15)The patient has watery diarrhea (watery stool)(Grade 2 or worse)
16)The patient has active multiple cancers
17)The patient has a history of receiving platinum-based antineoplastic agents (e.g. oxaliplatin and cisplatin)
18)A woman who is pregnant, nursing, or possibly pregnant or a man who is trying to conceive with a partner
19)The patient tests positive for HBsAg or antibodies to HCV (Date of testing required)
20)A patient who is deemed to need antiviral therapyb (as of enrollment) for HBV-related hepatitis
21)A lead investigator or the patient&#39;s primary physician otherwise deems that participation in this trial is not appropriate for the patient
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara
Organization Graduate School of Life Sciences, Kyushu University
Division name Department of Surgery and Science, Graduate School of Medical Sciences
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-631-2920
Email kscc2@cres-kyushu.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name KSCC Research Secretariat
Organization Clinical Research Support Center Kyushu
Division name KSCC Research Secretariat
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL 092-631-2920
Homepage URL
Email kscc2@cres-kyushu.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization Yakulto honsya co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 JCHO九州病院(福岡県)
高知医療センター(高知県)
兵庫県加古川医療センター(兵庫県)
宗像医師会病院(福岡県)
久留米大学(福岡県)
天草地域医療センター(熊本県)
岡山労災病院(岡山県)
大分赤十字病院(大分県)
薫風会佐野病院(兵庫県)
神戸市立医療センター中央市民病院(兵庫県)
熊本地域医療センター(熊本県)
光晴会病院(長崎県)
九州大学 消化器・総合外科,血液・腫瘍内科(福岡県)
JCHO人吉医療センター(熊本県)
公立陶生病院(愛知県)
慈泉会相澤病院(愛知県)
佐賀大学(佐賀県)
済生会福岡総合病院(福岡県)
田川市立病院(福岡県)
佐世保市総合医療センター(長崎県)
松山赤十字病院(愛媛県)
県立広島病院(広島県)
慈愛会今村病院分院(鹿児島県)
鹿児島厚生連病院(鹿児島県)
中津川市民病院(岐阜県)
三沢市立三沢病院(青森県)
札幌厚生病院(北海道)
香川大学(香川県)
琉球大学(沖縄県)
愛知県がんセンター愛知病院(愛知県)
社会保険田川病院(福岡県)
国立病院機構九州がんセンター 消化管外科,消化管・腫瘍内科(福岡県)
岐阜大学(岐阜県)
熊本大学(熊本県)
小牧市民病院(愛知県)
JA愛知厚生連江南厚生病院(愛知県)
JA愛知厚生連渥美病院(愛知県)
中津市立中津市民病院(大分県)
公立学校共済組合東海中央病院(岐阜県)
北海道大学(北海道)
国立病院機構九州医療センター(福岡県)
名古屋大学(愛知県)
長崎大学 移植・消化器外科,腫瘍外科(長崎県)
市立四日市病院(三重県)
医理会柿添病院(長崎県)
JCHO熊本総合病院(熊本県)
一宮市立市民病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
九州大学病院別府病院(大分県)
岐阜県多治見病院(岐阜県)
今給黎総合病院(鹿児島県)
鹿児島大学(鹿児島県)
国立病院機構別府医療センター(大分県)
公立病院機構大分医療センター(大分県)
慈愛会今村病院(鹿児島県)
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)
製鉄記念八幡病院(福岡県)
佐世保中央病院(長崎県)
大分県立病院(大分県)
大分大学(大分県)
国立病院機構南九州病院(鹿児島県)
国立病院機構豊橋医療センター(愛知県)
弘前大学(青森県)
福岡歯科大学医科歯科総合病院(福岡県)
国立病院機構福岡東医療センター(福岡県)
JCHO久留米総合病院(福岡県)
出水郡医師会広域医療センター(鹿児島県)
福岡市民病院(福岡県)
神戸大学(兵庫県)
田主丸中央病院(福岡県)
那覇市立病院(沖縄県)
獨協医科大学(栃木県)
苫小牧市立病院(北海道)
中濃厚生病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Updated survival analysis of a phase II study of SOX plus trastuzumab for HER2 positive advanced gastric cancer:(KSCC1501B)
Tetsuya Kusumoto, Tomomi Kashiwada, Katsunori Shinozaki, Satoshi Yuki, Masaaki Iwatsuki,  Hironaga Satake, Shoji Tokunaga, Yasunori Emi, Akitaka Makiyama, Hiroshi Saeki, Eiji Oki, Hideo Baba, Yoshihiko Maehara; Kyushu Study Group of Clinical Cancer (KSCC)
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 Completed
Date of protocol fixation
2015 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 13 Day
Last modified on
2019 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019474

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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