UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002180 |
|---|---|
| Receipt number | 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 17:33:55 |
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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 – 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
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
Sponsor or person
Institute
OGSG
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001077
