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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002785
Receipt No. R000003381
Scientific Title A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Date of disclosure of the study information 2009/11/19
Last modified on 2018/08/02

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Basic information
Public title A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Acronym A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Scientific Title A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Scientific Title:Acronym A Phase II study to confirm the effectiveness of TS-1 plus docetaxel for aged patients with advanced and/or metastatic gastric cancer (OGSG 0902)
Region
Japan

Condition
Condition advanced and/or metastatic gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the feasibility and effectiveness of TS-1 plus Docetaxel for aged patients with advanced and/or metastatic gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate (RECIST)
Key secondary outcomes Adverse Events/Incidence of AE.
Overall survival
Progression Free Survival
Time to Treatment Failure

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 Docetaxel and TS-1 (DS):A course includes docetaxel 40 mg/m2 on day 1 and TS-1 80 mg/m2/day for 14 days followed by 7 days of interval. Patients undergo repeats of this 3 week therapy until diagnoses of PD and/or untolerable adverse events or patients request to stop.
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 lesions for RECIST criteria
3) Patients older than 75 years
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
5) Patients who can intake orally
6) Patients' labo data within normal range
WBC:Between 4,000/mm3 and 12,000/mm3
Neutrocyte:More than 2,000/mm3
Hb:More than 8.0g/dL
Platelet:More than 100,000/mm3
Total bil.:Less than 1.5mg/dL
AST(GOT)ALT(GPT):Less than 2.5 times of upper normal range
Ccr:More than 40 mL/min
7) Patients without any prior chemotherapy are eligible and patients without any adverse events due to prior chemotherapy completed before 6 months are also eligible.
8) A predicted life expectancy of at least 3 months.
9) Written informed consent to participate in this study.
Key exclusion criteria 1) Patients with active double cancers
2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, uncontrolled DM, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
3) Patients with ascites and/or pleural fluid
4) Patients with any symptoms due to metastases to the central nervous system
5) Patients with any fresh bleeding from digestive tract
6) with severe ischemic cardiac diseases or arythmia which needs treatments
7) Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray and/or CT
8) History of serious drug hypersensitivity due to 5-FU, Docetaxel or Polysolbate 80
9) Patients with severe dysfunction of kidney, bone marrow and/or liver
10) Patients who need flucitosine, fenitoin or walfarin
11) Patients with untreated edema
12) Any other patient whom the physician in charge of the study judges to be unsuitable.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Imamura Hiroshi
Organization Toyonaka Municipal Hospital
Division name Dpt.Surgery
Zip code
Address 4-14-1,Shibaharacho,Toyonaka, 560-8565
TEL 06-6843-0101
Email imamurahiroshisakai@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Furukawa Hiroshi
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 imamurahiroshisakai@yahoo.co.jp

Sponsor
Institute Osaka Gastrointestinal cancer chemotherapy Study Group (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 市立堺病院(大阪府)、八尾市立病院(大阪府)、大阪労災病院(大阪府)、市立吹田市民病院(大阪府)、大阪医療センター(大阪府)、関西電力病院(大阪府)、ベルランド総合病院(大阪府)、大阪府立急性期・総合医療センター(大阪府)、箕面市立病院(大阪府)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 19 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 No longer recruiting
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 05 Day
Last follow-up date
2016 Year 01 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 19 Day
Last modified on
2018 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003381

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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