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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028309
Receipt No. R000032367
Scientific Title A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
Date of disclosure of the study information 2017/07/20
Last modified on 2019/07/30

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Basic information
Public title A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
Acronym A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
Scientific Title A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
Scientific Title:Acronym A multicenter phase II study of S-1+ramucirumab as first line treatment in elderly patients with advanced/recurrent gastric cancer(KSCC1701)
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 S-1+ramucirumab for the primary treatment of HER2-negative advanced gastric cancer in patients age 70 or older.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1-year survival rate
Key secondary outcomes Overall survival (OS)
Progression-free survival (PFS)
Response rate (RR)
safety (Safety)

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 The protocol treatment used in this study will be S-1+ramucirumab. If either S-1 or RAM will be discontinued in accordance with criteria during administration of the protocol treatment and the remaining medication will be administered alone, this monotherapy will be viewed as the protocol treatment.

1) Medications used
i.Tegafur, gimeracil, and oteracil: S-1
(Trade name: TS-1, S-1KK, EE S-1, NK S-1, S-1 NP, S-1 Meiji, Tenox, Temeral)
ii.Ramucirumab: RAM (Cyramza for intravenous infusion, 100 mg, 500 mg)

2) Medication dose and method of administration
Once a subject is enrolled, CReS Kyushu's Enrollment Allocation System will notify the patient's primary physician of the medication dose (the dose must be confirmed by the patient's primary physician).
i. S-1: A course of treatment will last 42 days.Treatment will continue unless any of the criteria for discontinuation of the protocol treatment,a pause during a course of S-1, or a schedule change (from courses to terms) or for a reduction in dose or discontinuation (of S-1) are met. In accordance with body surface area, S-1 will be administered in a dose of 40-60 mg once after breakfast and once after dinner. S-1 will be orally administered twice a day for 28 days (from after dinner on day 1 to after breakfast on day 29) with a respite of 14 days (starting S-1 administration after breakfast on day 1 or after breakfast on day 2 will not be permitted).
ii. Ramucirumab: Ramucirumab will be intravenously infused in a dose of 8 mg/kg on day 1 of the first course. Subsequent treatment will continue every 2 weeks unless criteria for discontinuation of the protocol treatment, for starting a course (or term) and criteria for administering RAM, or for a reduction in dose or discontinuation (of ramucirumab) are met.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Individuals who have consented in writing.
2) A lead investigator deems that the patient can be treated with the protocol.
3) Patients with gastric cancer that is not amenable to curative surgery or that is recurrent and that has been histopathologically confirmed to be primary adenocarcinoma of the stomach or gastroesophageal junction.
4) Patients with cancer that is HER2-negative (HER2-indeterminate are eligible).
5) Patients who are able to take medication orally.
6) Patients who are age 70 or older when they provide consent.
7) Patients with an ECOG Performance status of 0-1.
8) Criteria prior to treatment
i. Patients who have not previously undergone surgery.
ii. Patients who have previously undergone surgery
A) Patients who underwent a curative resection.
B) Patients who underwent non-curative surgery.
C) Exploratory laparotomy, bypass surgery, etc.
9) The patient has no severe dysfunction of major organs (bone marrow,liver,kidneys,heart,lungs,etc.) and the patient's laboratory results from up to 14 days prior to enrollment meet the following criteria:
i. Neutrophil count>=1,500/mm3
ii. Platelet count>=100,000/mm3
iii. Hemoglobin >=9.0 g/dL
iv. Total bilirubin=<1.5 mg/dL
v. AST=<3xULN (A level of =<5xULN is permitted for patients with liver metastasis)
vi. ALT=<3xULN (A level of 5xULN is permitted for patients with liver metastasis)
vii. Albumin>=2.5 g/dL
viii. Dipstick urinalysis results in a reading=<1+ protein.
ix. Creatinine clearance>=40 mL/min
x. Clotting: Patients with appropriate clotting as defined by an international normalized ratio (INR) of 1.5 or less and a partial thromboplastin time (PTT) no more than 5 seconds above the ULN (when not receiving anticoagulant therapy).
Key exclusion criteria 1) Patients who have severe drug hypersensitivity.
2) Patients who have undergone major surgery up to 28 days prior to enrollment or in whom a central venous access device has been placed up to 7 days prior to the initial treatment. Patients who are scheduled to undergo major surgery during the study period. Patients with a severe hemorrhagic disorder within 12 weeks of enrollment.
3) Patients who have had a gastrointestinal perforation and/or fistula up to 6 months prior to enrollment.
4) Patients with a serious or non-healing wound up to 28 days prior to enrollment.
5) Patients who have had deep vein thrombosis, pulmonary embolism, or some other major form of thromboembolism up to 3 months prior to enrollment.
6) The patient has experienced any arterial thromboembolic events, within 6 months prior to first protocol therapy.
7) Patients receiving chronic administration of a non-steroidal antiinflammatory drug or some other antiplatelet drug.
8) Patients with an active infection.
9) Patients with hypertension (>160 mmHg systolic or > 100 mmHg diastolic for >4 weeks) that cannot be adequately controlled with 2 antihypertensives.
10) Patients with diabetes mellitus that cannot be controlled adequately with medication.
11) Patients with heart disease that may pose a problem.
12) Patients with severe pulmonary disease.
13) Patients with a psychiatric disorder.
14) Patients with active gastrointestinal tract bleeding requiring repeated transfusions.
15) Patients receiving phenytoin, warfarin potassium, or flucytosine.
16) Patients with diarrhea (Grade 2 or worse).
17) Patients with active multiple cancers.
18) Men who wish to conceive with a partner.
19) Patients with hepatic cirrhosis or active hepatitis.
20) Patients with cirrhosis, with a history of hepatic encephalopathy, or with clinically significant ascites.
21) Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Suyama
Organization Kumamoto University Hospital
Division name Cancer Center
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL 092-409-3500
Email sanae.sakamoto@ks-cc.or.jp

Public contact
Name of contact person
1st name KSCC
Middle name
Last name Research Secretariat
Organization Kyushu Study group of Clinical Cancer
Division name KSCC Research Secretariat
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-409-3500
Homepage URL
Email sanae.sakamoto@ks-cc.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization the Headquarters of Eli Lilly Japan
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 Kyushu University Hospital Clinical Examination Ethics Review Committee
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel 092-641-1151
Email byssien@jimu.kyushu-u.ac.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 慈愛会今村総合病院(鹿児島県)
長崎大学 移植・消化器外科(長崎県)
飯塚病院(福岡県)
国立病院機構嬉野医療センター(佐賀県)
出水郡医師会広域医療センター(鹿児島県)
国立病院機構名古屋医療センター(愛知県)
那覇市立病院(沖縄県)
JCHO九州病院(福岡県)
伊万里有田共立病院(佐賀県)
田川市立病院(福岡県)
熊本大学 消化器外科(熊本県)
済生会福岡総合病院(福岡県)
宗像医師会病院(福岡県)
社会保険田川病院(福岡県)
長崎大学 腫瘍外科(長崎県)
中津市立中津市民病院(大分県)
国立病院機構別府医療センター(大分県)
鹿児島厚生連病院(鹿児島県)
高知医療センター(高知県)
松山赤十字病院(愛媛県)
JCHO久留米総合病院(福岡県)
佐賀大学 血液・呼吸器・腫瘍内科(佐賀県)
佐世保市総合医療センター(長崎県)
九州大学 消化器・総合外科(福岡県)
九州大学病院別府病院(大分県)
公立八女総合病院(福岡県)
製鉄記念八幡病院(福岡県)
公立学校共済組合東海中央病院(愛知県)
神戸市立医療センター中央市民病院(兵庫県)
JCHO人吉医療センター(熊本県)
伊那中央病院(長野県)
産業医科大学 第一外科(福岡県)
産業医科大学 第三内科(福岡県)
国立病院機構九州医療センター(福岡県)
香川大学 腫瘍センター(香川県)
国立病院機構大分医療センター(大分県)
大分中村病院(大分県)
鹿児島大学 消化器・乳腺甲状腺外科学(鹿児島県)
済生会川内病院(鹿児島県)
神戸大学 食道胃腸外科(兵庫県)
大分赤十字病院(大分県)
獨協医科大学 第一外科(栃木県)
久留米大学 外科/がん集学治療センター(福岡県)
公立学校共済組合九州中央病院(福岡県)
聖マリアンナ医科大学 消化器・一般外科/臨床腫瘍学(神奈川県)
大分県立病院(大分県)
国立病院機構福岡東医療センター(福岡県)
県立広島病院(広島県)
NTT東日本札幌病院(北海道)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 20 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
2017 Year 07 Month 06 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2021 Year 11 Month 30 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 07 Month 20 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032367

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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