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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000714
Receipt No. R000000849
Scientific Title A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Date of disclosure of the study information 2007/05/17
Last modified on 2018/07/16

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Basic information
Public title A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Acronym A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Scientific Title A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Scientific Title:Acronym A feasibility test on a postoperative Docetaxel plus TS-1 therapy for the patients with stage IIIA or stage IIIB gastric cancer (OGSG-0604)
Region
Japan

Condition
Condition Stage IIIA or stage IIIB gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A phase II study, that a combination of Docetaxel plus TS-1 is administered to patients with stage IIIA or stage IIIB gastric cancer, postoperatively, is carried out to confirm the feasibility or safety of the treatment.
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 course
Key secondary outcomes Incidence of adverse events, Time to recurrence, survival, the ratio of the patients who completed the course of
TS-1 in a year

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 DXT 40mg/m2 is administered by drip infusion on day 1.
TS-1 80 mg/m2/day is administered orally between day 1 and day 14.
It takes 21 days for the one course
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. histologically proven gastric carcinoma
2. D2 lymph node dissection and curative resection (R0) at the prior surgery
3. patients with stage IIIA or stage IIIB gastric cancer
4. age: 20<= and =<80 years old
5. PS(ECOG): 0 &#8211; 1
6. without any prior radiation therapy, chemotherapy, or hormone therapy
7. patients who can take medicine orally
8. without any other severe diseases
WBC 4,000<= and => 12,000/mm3
Neutrocyte 2,000mm3<=
Hemoglobin 9.0 g.dl <=
Platelet 100,000/mm3 <=
Total bilirubin 1.5 mg/dl =>
AST, ALT normal range in each institute
Serum creatinin 1.2 mg/dl >=
Creatinin clearance 60 ml/min/body <=
**Cockcroft-Gault method is available
9. written informed consents
Key exclusion criteria 1. with double cancer and/or multiple cancer
2. patients who cannot take TS-1
3. patients who need flucitosine, fenitoin or warfarin
4. with allergic history against medicines
5. with severe allergic response against polysolbate 80
6. without any disorder on the chest X-ray or CT, or interstitial
pneumonitis or pulmonary fibrosis
7. with other severe diseases (intestinal paralysis, intestinal obstruction, uncontrolled DM, cardiac failure, or liver dysfunction)
8. watery diarrhea
9. pregnant and/or nursing women
10. men who need their children in future
11. liver cirrhosis or active hepatitis
12. cavity fluid which should be taken out
13. doctors' stop not to register to the study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeyuki Tamura
Organization Kansai Rosai Hospital
Division name Department of surgery
Zip code
Address 660-8511 3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL 06-6416-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Furukawa
Organization Kinki University Faculty of Medicen
Division name Department of surgery
Zip code
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL 072-366-0221
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 05 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007%2Fs10120-013-0273-7
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 Completed
Date of protocol fixation
2006 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2013 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 05 Month 10 Day
Last modified on
2018 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000849

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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