UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer
Title of the study (Brief title)	Phase II of S-1 plus CDDP for elderly gastric cancer (SPEL)
Region	Japan

Condition
Condition	Elderly patients with metastatic gastric cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of combination therapy with S-1 plus cisplatin in elderly patients with metastatic gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Response rate, progression-free survival, time to treatment failure, adverse events

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	5-week cycle of intravenous cisplatin (30-60 mg/m2 on day 8) and oral administration of S-1(25-60mg, twice a day, between days 1 and 21)
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	76 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pathologically proven adenocarcinoma (papillary, tubular, or poorly differentiated), signet ring cell carcinoma, mucinous adenocarcinoma, or hepatoid adenocarcinoma 2) Unresectable advanced or recurrent disease 3) Age over 76 years 4) ECOG performance status (PS) of 0 or 1 5) No previous chemotherapy, or radiotherapy except post-operative adjuvant chemotherapy with fluoropyrimidine alone or fluoropyrimidine/leucovorin as long as it was completed at least 24 weeks prior to registration, or either hormone therapy as long as it was completed at least 24 weeks prior to registration 6) Adequate food intake 7) Negative HER2 status 8) Adequate organ function as defined below: a) Neutrophil count >= 1,500 /mm3 b) Platelet count >= 100000 /mm3 c) Total bilirubin =< 1.5 mg/dL d) AST =< 100 IU/L (<200 IU/L in patients with liver metastasis) e) ALT =< 100 IU/L (<200 IU/L in patients with liver metastasis) f) Serum creatinine =< 1.5 mg/dL and Ccr >= 30mL/min 9) Written informed consent
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 2) Body temperature >= 38C 3) Severe mental disease 4) Current treatment with systemic steroids 5) Uncontrolled diabetes mellitus 6) Unstable angina pectoris within the past 3 weeks, or previous myocardial infarction within the past 6 months 7) Evidence of any other serious disease; renal failure, hepatic failure, interstitial pneumonia, or pulmonary fibrosis 8) Active bleeding 9) Massive ascites 10) Massive pleural effusion 11) Judged ineligible by the clinical investigators
Target sample size	40

Research contact person
Name of lead principal investigator	Tetsuya Hamaguchi
Organization	National Cancer Center Hospital
Division name	Gastrointestinal Oncology Division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	thamaguc@ncc.go.jp

Public contact
Name of contact person	Satoru Iwasa
Organization	National Cancer Center Hospital
Division name	Gastrointestinal Oncology Division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	siwasa@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

Funding Source
Organization	Japan Society of Clinical Oncology
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 19 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 11 Month 06 Day
Anticipated trial start date	2012 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://meetinglibrary.asco.org/content/175179-195
Results
Other related information

Management information
Registered date	2012 Year 11 Month 17 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010981