UMIN-CTR Clinical Trial

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

gastric cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

1-year survival rate

Key secondary outcomes

Overall survival (OS)
Progression-free survival (PFS)
Response rate (RR)
safety (Safety)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name

Organization

the Headquarters of Eli Lilly Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

07

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

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 related information

Registered date

2017

Year

07

Month

20

Day

Last modified on

2021

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032367