UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer (OGSG 0404)
Acronym	OGSG0404
Scientific Title	A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer (OGSG 0404)
Scientific Title:Acronym	OGSG0404
Region	Japan

Condition
Condition	advanced and/or recurrent gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Effectiveness and feasibility of TS-1 to the senior patients older than 75 years old are detected through a phase II study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Aanti-cancer effects (Response Rate, Response Period)
Key secondary outcomes	Feasibility (Incidence of Adverse Events), Overall Survival, Progression Free Survival, Time to Treatment Failure, Relationship to the score of MMSE

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Dose by Ccr: Ccr 80ml/min<= body surface 1.5m2<=:120mg/body/day, 1.25-1.5:100mg/body/day, 1.25>:80mg/Body/day Ccr 50mg/min<= and 80mg/min>:1 dose down(1.5m2<=:100mg/body/day, 1.25-1.5: 80mg/body/day, 1.25>: 50mg/body/day) Ccr 30mg/min<= and 50mg/min>:2 dose down(1.5m2<=: 80mg/body/day, 1.25-1.5: 50mg/body/day, 1.25>: 40mg/body/day) TS-1 is administered 4 weeks continuously and 2 weeks off, sebsequently
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. histologically proven gastric cancer 2. with measurable lesion on CT 3. aged over 75years old 4. PS:0-2 5. patients who can eat orally 6. Labo Data 1) WBC 4,000<= and <12,000 mm3 2) Neutrocyte 2,000mm3<= 3) Platelet 100,000mm3<= 4) Hemoglobin 8.0 g/dl<= 5) AST,ALT <=100 IU/L or <=150 IU/L for patients with liver metastasis 6) Total Bil.: within normal range in each institute 7) serum creatinin <=1.2 mg/dl 8) expected creatinin clearance: >=30 mg/min by Cockcroft-Gault 7. without prior treatment(radiation therapy, chemotherapy or hormon therapy). with postoperative adjuvant chemotherapy which has completed 6 months before 8. patients expected more than 3 months survival 9. with written informed consent 10. expected sufficient compliance 11. with MMSE data before treatment
Key exclusion criteria	1. with active double cancer 2. with severe other diseases(intestinal paralysis, ileus, intersitial pneumonitis or plumonary fibrosis, uncontrolled DM, cardiac failure, renal dysfunction, liver dysfunction, respiratory dysfunction) 3. severe ascites and/or pulmonary fluid 4. metastasis on central nerve system with symptom 5. fresh bleeding on digestive tract 6. with severe ischemic cardiac disease which needs treatment 7. hypersensitive response to TS-1 8. with severe bone marrow supplession, renal dysfunction or liver dysfunction 9. under administration of flucytosine 10. patients who underwent postoperative adjuvant chemotherapy of TS-1 11. doctor's exclusion due to some reason
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Imamura Hiroshi
Organization	Toyonaka City Hospital
Division name	Department of Surger
Zip code
Address	4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL	06-6843-0101
Email	imamurahiroshisakai@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Imamura Hiroshi
Organization	Toyonaka City Hospital
Division name	Department of Surger
Zip code
Address	4-14-1, shibaharacho, Toyonka City, Osaka, Japan, 560-8565
TEL	06-6843-0101
Homepage URL
Email	imamurahiroshisakai@yahoo.co.jp

Sponsor
Institute	Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Osaka Clinical Study Supporting Organization
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	2007 Year 04 Month 05 Day

Related information
URL releasing protocol	http://www.tandfonline.com/doi/abs/10.1179/1973947813Y.0000000116?journalCode=yjoc20
Publication of results	Published

Result
URL related to results and publications	http://www.tandfonline.com/doi/abs/10.1179/1973947813Y.0000000116?journalCode=yjoc20
Number of participants that the trial has enrolled	35
Results	The response rate (RR) was 14.3% and the median overall survival was 14.6 months.
Results date posted	2021 Year 11 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2013 Year 02 Month 06 Day
Baseline Characteristics	Chemotherapy-naive patients aged over 75 years with adverse gastric cancer
Participant flow	Thirty-five patients were enrolled.
Adverse events	Grade 3 or more severe adverse events consisted of anemia (3%), neutropenia (3%), anorexia (3%), and fatigue (6%). There were no treatment-related deaths.
Outcome measures	response rate (RR) overall survival (OS)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date	2004 Year 09 Month 01 Day
Last follow-up date	2010 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2007 Year 03 Month 29 Day
Last modified on	2021 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000796