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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000686
Receipt No. R000000823
Scientific Title A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer.
Date of disclosure of the study information 2007/04/23
Last modified on 2009/01/09

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Basic information
Public title A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer.
Acronym OGSG 0502
Scientific Title A phase II study of preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy for type 4 gastric cancer.
Scientific Title:Acronym OGSG 0502
Region
Japan

Condition
Condition For patients with type 4 gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For patients with type 4 gastric cancer which is resectable, a preoperative S-1 plus Paclitaxel combination therapy and postoperative Paclitaxel followed by S-1 therapy is evaluated on its response or feasibility.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes "The ratio of the patients who completed the regimen
The ratio of administered dose to the planed dose."
Key secondary outcomes Response Rate
Overall Survival
Disease Free Survival
Histological CR

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 Treatment Methods
A three course S-1 plus Paclitaxel (S-1[80mg/day] between day 1 and 14, and Paclitaxel [50mg/m2] on day 1 and 8, followed by 7 days rest) is administered before surgery.. Surgical operation is performed 21-35 days after chemotherapy.
Fourteen to fifty-six days after surgical operation, a three course of Paclitaxel ( 50mg/m2 on day 1 and 8, followed by 14 days rest) is administered followed by a eight course of S-1 (80mg/day between day 1 and 14 followed by 7 days rest).
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.histologically proven gastric cancer
2.type 4 gastric cancer
3.N0-2 (not bulky)
4.curative resection A or B in the preoperative diagnosis,
5.Thracotomy is not necessary
6.PS 0-1 in ECOG
7.Age: 20-75 yo
8.No history of prior surgery or chemotherapy for cancer
9.No obvious bleeding from lesion or no obstruction of intestine
10.sufficient oral intake
11.No organ failure detected by blood examination
12.CCr is over 50ml/min in Cockcroft-Gault method
13.No severe complications or no active double cancer except resected cancer in situ
14.written informed consent
Key exclusion criteria 1.patients with severe diseases (non-treated ischemic cardiac disease, arrhythmia, liver cirrhosis, nterstitial pneumonia, fresh bleeding which needs transfusion, mental disorder, uncontrolled DM, intestinal obstruction, etc.)
2.febrile infection
3.allergy against polyoxyethylene-castor oil
4.under pregnancy or nursing
5.receiving steroids
6.receiving flucytosine, phenytoin or warfarin
7.doctors' decision
Target sample size 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujitani Kazumasa
Organization National Hospital Orgamnzation
Osaka Medical Center
Division name Dpt.Surgery
Zip code
Address 2-1-14 2-1-14.Houenzaka, chuo-ku, Osaka, 540-0006
TEL 06-6942-1331
Email

Public contact
Name of contact person
1st name
Middle name
Last name Furukawa Hiroshi
Organization Sakai City Hospital
Division name Director
Zip code
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL 072-221-1700
Homepage URL
Email

Sponsor
Institute OGSG
Institute
Department

Funding Source
Organization NPO Osaka Chinical 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 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Terminated
Date of protocol fixation
2005 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 04 Month 19 Day
Last modified on
2009 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000823

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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