Unique ID issued by UMIN | UMIN000017550 |
---|---|
Receipt number | R000019414 |
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 |
Date of disclosure of the study information | 2015/05/29 |
Last modified on | 2019/03/01 17:08:07 |
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
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
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
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
Japan |
Gastric Cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Phase II
Response proportion (RECISTv1.1)
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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).
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
70
1st name | |
Middle name | |
Last name | Yoshihiko Maehara |
Graduate School of Life Sciences, Kyushu University
Department of Surgery and Science, Graduate School of Medical Sciences
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
092-631-2920
kscc2@cres-kyushu.or.jp
1st name | |
Middle name | |
Last name | KSCC Research Secretariat |
Clinical Research Support Center Kyushu
KSCC Research Secretariat
3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
092-631-2920
kscc2@cres-kyushu.or.jp
Kyushu Study group of Clinical Cancer
Yakulto honsya co.
Profit organization
NO
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)
2015 | Year | 05 | Month | 29 | Day |
Partially published
Completed
2015 | Year | 04 | Month | 22 | Day |
2015 | Year | 06 | Month | 01 | Day |
2015 | Year | 05 | Month | 13 | Day |
2019 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019414