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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002180
Receipt No. R000001077
Scientific Title Phase II study of Docetaxel and CDDP and 5-FU for metastatic esophageal cancer
Date of disclosure of the study information 2009/07/10
Last modified on 2011/04/06

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Basic information
Public title Phase II study of Docetaxel and CDDP and 5-FU for metastatic esophageal cancer
Acronym OGSG 0403
Scientific Title Phase II study of Docetaxel and CDDP and 5-FU for metastatic esophageal cancer
Scientific Title:Acronym OGSG 0403
Region
Japan

Condition
Condition Esophageal cancer with distant metastasis (Stage IVb or stage IVa with N4)
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The effectiveness and feasibility of the combination therapy of TXT, CDDP and 5-FU are evaluated in a phase II study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes feasibility, survival period, survival time before progression
(Time To Progression: TTP)

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 Course 1 Course 2
Day 1 2 3 4 5 29 30 31 32 33
TXT O O
CDDP O O
5-FU --------- --------------

5-FU 600mg/m2 is administered (civ) between day 1 and day 5
CDDP 70 mg/m2 is administered (iv) by 120 minutes on day 1.
TXT 60 mg/m2 is administered (iv) by more than 60 minutes on day 1.
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) with measurable lesion
2) esophageal cancer (Squamous cell carcinoma) diagnosed histologically or
cytologically
3) without any prior therapy (surgery , chemotherapy or radiation therapy)
4) with distant metastasis
5) age: more than 20 years old and less than 75 ys. Old
6) Performance Status: 0 &#8211; 2
7) without any disorder in the important organs
1. WBC: 4,000 <= and <= 12,000/mm3
2. Neutrocyte >= 2,000 /mm3
3. Platelet: >= 10,000 /mm3
4. Hemoglobin: >= 9.0 g/dl
5. Total Bilirubin: <= 1.5 mg/dl
6. GOT, GPT: less than 2.5 times of normal range of each institute
7. serum Creatinin: <= 1.2 mg/dl
Or Creatinin Clearance: more than 60 ml/min
*Crockcroft-Gault method can be used instead of CC
8. PaO2: >= 70 torr (room air)
8) longer than 3 months of expected survival
9) with written informed consent
Key exclusion criteria 1) severe disorders in the other organs
(cardiac disorder, pulmonary fibrosis or interstitial pneumonia, liver dysfunction)
2) brain metastasis with symptoms
3) edema which needs treatment
4) severe infectious disease
5) with high fever upper than 38 0C
6) with active double cancer
7) women under pregnancy and/or nursing or women who expects pregnancy
8) with a history of severe allergic reaction against medicines
9) uncontrolled cavity fluid in the chest, abdomen or heart
10) doctor's decision not to register to this regimen
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeyuki Tamura
Organization Kansai Rosai Hospital
Division name Dpt. 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 Furukawa Hiroshi
Organization Sakai City Hospital
Division name Director
Zip code
Address 1-1-1,Minamiyasuicho,Sakai-ku,Sakai, 590-0064
TEL
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
2009 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2004 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 01 Day
Last follow-up date
2010 Year 02 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
2009 Year 07 Month 10 Day
Last modified on
2011 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001077

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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