UMIN-CTR Clinical Trial

Basic information
Public title	Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1
Acronym	Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1
Scientific Title	Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1
Scientific Title:Acronym	Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1
Region	Japan

Condition
Condition	senior citizen's gastric cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine a clinical effect and safety of the TS-1 administering to inoperable or recurrent senior citizen's gastric cancer by 75 years old or more.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	TTF, OS, Safety, Home treatment period, home treatment rate

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	TS1: 50 or 80 or 100 or 120 mg/body/day, orally 28 days, every 6 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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)With pathologically proven gastric cancer 2) With at least one measurable lesion (RECIST) 3) Age 75 years old or more 4) ECOG performance status<=2 5) Sufficient organ functions 6) No prior chemotherapy 7) Life expectancy estimated>=3 months 8) With written informed consent 9) Case who has understanding that can secure S-1 compliance enough
Key exclusion criteria	1.History of severe drug allergic reaction 2.Severe Bone marrow suppression,renal and liver function disturbance 3.Concomitant therapy with another anticancer drug or flucytocine 4.Marked pleural effusion or ascites 5.Symptomatic brain metastasis 6.Intestinal fresh hemorrhage 7.Active secondary cancer 8.Accompanied serious diseases 9.Severe Ischemic heart disease or Arrhythmia which requires treatment 10.Watery diarrhea 11.Decision as ineligible by principal investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Minoru Kurihara
Organization	The Tokyo cooperative Oncology Group
Division name	Director
Zip code
Address	1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The Tokyo cooperative Oncology Group
Division name	Secretariat
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	The Tokyo cooperative Oncology Group
Institute
Department

Funding Source
Organization	The Tokyo cooperative Oncology Group
Organization
Division
Category of Funding Organization	Self funding
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	2005 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.springerlink.com:80/content/h0w03400l76922m8/?p=9636b082bb344721ae0e0bfc46bf95ff&pi=1
Number of participants that the trial has enrolled
Results	Thirty-three patients were enrolled. Pharmacokinetics of S-1 was studied in six patients, and the maximum plasma concentrations of respective metabolites after S-1 administration were found to be similar to those reported for younger cancer patients. The overall response rate in 33 patients was 21.2% (95% CI, 10.7-37.8%), and median progression-free survival was 3.9 months, with a median overall survival of 15.7 months. Frequently noted adverse events include leukopenia, neutropenia, anemia, anorexia, and fatigue. As for serious adverse events, relatively higher frequencies of anemia (9%) and anorexia (12%) of grade 3 severity were found, but there were no grade 4 episodes. Conclusions: The results suggest that S-1 monotherapy is safe and useful for elderly patients with unresectable advanced or recurrent gastric cancer when the dose is selected with caution, taking into account renal function.
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	Completed
Date of protocol fixation	2004 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date	2004 Year 06 Month 01 Day
Last follow-up date	2007 Year 05 Month 01 Day
Date of closure to data entry	2007 Year 05 Month 01 Day
Date trial data considered complete	2007 Year 11 Month 01 Day
Date analysis concluded	2007 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 11 Month 18 Day
Last modified on	2009 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000365

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.