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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002041
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002486

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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