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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009349
Receipt No. R000010981
Scientific Title Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer
Date of disclosure of the study information 2012/11/19
Last modified on 2017/05/22

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Basic information
Public title Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer
Acronym Phase II of S-1 plus CDDP for elderly gastric cancer (SPEL)
Scientific Title Multicenter phase II study of combination therapy with oral S-1 plus cisplatin in elderly patients with metastatic gastric cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Tetsuya Hamaguchi
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email thamaguc@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Iwasa
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://meetinglibrary.asco.org/content/175179-195
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

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 11 Month 06 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010981

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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