UMIN-CTR Clinical Trial

Public title

A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501A)examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy

Acronym

A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501A)examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy

Scientific Title

A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501A)examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy

Scientific Title:Acronym

A phase II clinical trial (KSCC/HGCSG/CCOG/PerSeUS1501A)examining oxaliplatin + S-1 for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy

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 oxaliplatin + S-1 (SOX) for treatment of HER2-negative advanced/recurrent gastric cancer previously untreated with chemotherapy.
* To examine the efficacy and safety of SOX+trastuzumab for treatment of HER2-positive advanced/recurrent gastric cancer previously untreated with chemotherapy in trial KSCC 1501B.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response proportion (RECISTv1.1)

Key secondary outcomes

Safety profile*1, progression-free survival (PFS), overall survival (OS),Response proportion (<=75), 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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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 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

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 (the patient is suitable for enrollment)
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-negative
6)The patient has not previously received chemotherapy, immunotherapy, or radiation therapy (except for local irradiation of bone metastases)
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'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's laboratory results from up to 14 days prior to enrollment fall within the criteria
i)WBC count <=12,000/mm3
ii)Neutrophil count >=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

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, or S-1)
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 (patients with controlled diabetes who are receiving insulin treatment are eligible for enrollment)
7)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'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's primary physician otherwise deems that participation in this trial is not appropriate for the patient

Target sample size

70

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

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

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name

Organization

Yakulto honsya co.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

JCHO九州病院（福岡県）
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）
佐世保市立総合病院（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）
長崎大学（長崎県）
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）
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）
豊見城中央病院（沖縄県）
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）
愛知県がんセンター中央病院（愛知県）
種子島医療センター（鹿児島県）

Date of disclosure of the study information

2015

Year

05

Month

29

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2015

Year

05

Month

13

Day

Last modified on

2019

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019414