UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseII study of S-1/CDDP therapy for Gastric Cancer that Recurs After Adjuvant Chemotherapy with S-1
Title of the study (Brief title)	PhaseII study of S-1/CDDP therapy for Gastric Cancer that Recurs After Adjuvant Chemotherapy with S-1(KSCC1001)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of S-1/CDDP therapy for gastric cancer that recurs after adjuvant chemotherapy with S-1.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival
Key secondary outcomes	Response rate Disease Control Rate Overall Survival Time to Treatment Failure 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	S-1 80mg/m2 (day1-21) CDDP 60mg/m2 i.v. (day8) to be repeated every 5 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Written informed consent. 2. Appropriate for the study at the physician's assessment. 3. Histologically confirmed gastric adenocarcinoma. 4. Patients who have HER2-nagative cancer confirmed with IHC and/or FISH. (IHC 0 or 1+ or 2+ and FISH negative(HER2/CEP17<2.0)) 5.Treated with S-1 adjuvant chemotherapy after gastrectomy and lymph node dissection and with no residual tumor. 6. S-1 adjuvant chemotherapy continued at least 6 months. 7. No neo-adjuvant therapy. 8. No prior therapy for recurrent gastric cancer. 9. 1)measurable lesion based on the RECIST criterion. 2)evaluable lesion in contrast enhanced CT, etc. 10. ECOG performance status of 0-1. 11. 20 years of age or older. 12. Required baseline laboratory parameters .(within 14 days before registration): WBC >= 3000/mm3 , <12,000/mm3 Neu >= 1,500/mm3 Plt >= 100,000/mm3 Hb >= 9.0g/dl T-Bil <= 2.0mg/dl AST <= 100U/L (in case of hepatic metastatic patients: <= 200U/L) ALT <= 100U/L (in case of hepatic metastatic patients: <= 200U/L) Cre < 1.5mg/dl CCr >= 50mL/min HER2 negative.(IHC 0 or 1+ or 2+ and FISH negative(HER2/CEP17<2.0)) 13. be able to take oral drugs.
Key exclusion criteria	1. Active other malignancies. 2. Prior S-1 plus other anti-cancer drugs combination chemotherapy. 3. Adjuvant chemotherapy other than S-1 mono therapy. 4. Requiring flucytosine, phenytoin, Warfarin Potassium. 5. History of the severe(grade3 or 4) hypersensitivity 6. Co-mobility, such as interstitial lung disease, lung fibrosis, intestinal paralysis, ileus, uncontrolled diabetes, uncontrolled hypertension, heart failure, serious arrhythmia, myocardial infarction, unstable angina, hepatic failure, liver cirrhosis, requiring anticoagulation therapy, requiring steroid drug, and other severe complication. 7. Active infection 8. Infection with hepatitis B or C virus 9. Watery stools or diarrhea 10. Pregnant or lactating woman 11. No birth-control 12. Mental disorder, central nerve disorder. 13. Infection with HIV virus. 14. Not appropriate for the study at the physician's assessment
Target sample size	44

Research contact person
Name of lead principal investigator	Yoshihiko Maehara
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
TEL	092-631-2920
Email	kscc2@cres-kyushu.or.jp

Public contact
Name of contact person	KSCC
Organization	Clinical Research Support Center Kyushu
Division name	KSCC
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
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	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

九州大学(福岡県)、国立病院機構九州がんセンター(福岡県) 、公立学校共済組合九州中央病院（福岡県）、済生会福岡総合病院(福岡県)、製鉄記念八幡病院(福岡県) 、国立病院機構福岡東医療センター（福岡県）、社会保険田川病院（福岡県)、社会保険仲原病院（福岡県）、久留米大学(福岡県)、久留米大学医療センター(福岡県) 、社会保険久留米第一病院 　(福岡県) 、公立八女総合病院(福岡県) 、大牟田市立病院（福岡県）、宗像医師会病院（福岡県）、福岡市民病院(福岡県) 、福岡大学病院(福岡県) 、福岡歯科大学医科歯科総合病院　(福岡県)、佐世保市立総合病院(長崎県)、長崎大学(長崎県)、健康保険諫早総合病院（長崎県）、長崎百合野病院（長崎県）、済生会熊本病院(熊本県)、熊本大学(熊本県)、健康保険人吉総合病院(熊本県)、健康保険熊本総合病院（熊本県）、熊本地域医療センター(熊本県)、大分県立病院（大分県）、大分赤十字病院(大分県)、国立病院機構大分医療センター(大分県)、国立病院機構別府医療センター(大分県)、国立病院機構都城病院(宮崎県) 、国立病院機構南九州病院(鹿児島県)、今給黎総合病院(鹿児島県) 、鹿児島大学(鹿児島県)、鹿児島共済会南風病院(鹿児島県)、済生会川内病院（鹿児島県）、鹿児島県立薩南病院（鹿児島県）、広島赤十字・原爆病院(広島県)、松山赤十字病院(愛媛県)、神戸市立医療センター中央市民病院（兵庫県）、独立行政法人 労働者健康福祉機構 岡山労災病院（岡山県）、田川市立病院（福岡県）、三木市立三木市民病院（兵庫県）、九州大学病院別府病院（大分県）、伊万里有田共立病院（佐賀県）、広島赤十字・原爆病院（広島県）

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 03 Day
Anticipated trial start date	2012 Year 07 Month 03 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 09 Month 30 Day
Last modified on	2017 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005148