UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002041 |
|---|---|
| Receipt number | R000002486 |
| Scientific Title | A phase I trial of combination chemotherapy with docetaxel and 5-fluorouracil (DF) for advanced esophagogastric carcinoma (KDOG 0902 P1) |
| Date of disclosure of the study information | 2009/06/03 |
| Last modified on | 2015/04/11 16:14:24 |
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Basic information
Public title
A phase I trial of combination chemotherapy with docetaxel and 5-fluorouracil (DF) for advanced esophagogastric carcinoma (KDOG 0902 P1)
Acronym
A phase I trial of combination chemotherapy with docetaxel and 5-fluorouracil (DF) for advanced esophagogastric carcinoma (KDOG 0902 P1)
Scientific Title
A phase I trial of combination chemotherapy with docetaxel and 5-fluorouracil (DF) for advanced esophagogastric carcinoma (KDOG 0902 P1)
Scientific Title:Acronym
A phase I trial of combination chemotherapy with docetaxel and 5-fluorouracil (DF) for advanced esophagogastric carcinoma (KDOG 0902 P1)
Region
| Japan |
Condition
Condition
advanced or recurrent esophagogastric carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the maximum tolerated dose and the recommended dose of docetaxel combined with 5-fluorouracil for previously treated advanced or recurrent esophagogastric carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To estimate the maximum tolerated dose and the recommended dose
Key secondary outcomes
safety
efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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 5-fluorouracil
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed esophageal or gastric carcinoma.
2. measurable or evaluable lesion
3. this chemotherapy is second or third line
4. No previous use of Taxan
5. Performance Status:0-2(ECOG)
6. Patients of age =>20 at the registration
7. Life expectancy more than 12 weeks
8. Sufficient organ functions within two weeks before registration
1) leukocytes =>3,000/mm3
2) neutrocytes =>1,500/mm3
3) platelets =>100,000/mm3
4) hemoglobin =>8.0g/dl
5) AST(GOT)/ALT(GPT) <=100IU/l
6) total bilirubin <=1.5mg/dl
7) serum creatinine <=1.50mg/dl
8) normal ECG
9. Written informed consent
Key exclusion criteria
1. Administration of the blood transfusion or G-CSF within 7 days before registration
2. History of serious drug hypersensitivity
3. Active infection
4. Watery diarrhea
5. Uncontrolled ileus
6. Active gastrointestinal bleeding
7. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc)
8. Symptomatic brain metastasis
9. Active synchronous or metachronous malignancy, excepting for esophageal and gastric carcinoma
10. Severe abnormality of ECG, severe heart disease (congestive heart failure, symptomatic ischemic heart disease, uncontrolled arrhythmia, history of myocardial infarction within 12 months, or etc)
11. Severe mental disorders, neurological disease
12. Pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy
13. Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wasaburo Koizumi |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine, Department of Gastroenterology
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 | 06 | Month | 03 | 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
| 2009 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | 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 | 06 | Month | 03 | Day |
Last modified on
| 2015 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002486
