UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008400 |
|---|---|
| Receipt number | R000009877 |
| Scientific Title | Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer |
| Date of disclosure of the study information | 2012/07/11 |
| Last modified on | 2016/07/11 19:55:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer
Acronym
Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer
Scientific Title
Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer
Scientific Title:Acronym
Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy, we conduct phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for esophageal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
objective response rate
Key secondary outcomes
duration of response, time to progression, time to treatment failure, overall survival, feasibility
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/cisplatin/5-fluorouracil (docetaxel 60 mg/sm day1, cisplatin 70 mg/sm day1, 5-fluorouracil 600 mg/sm day1-5) given every 4 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Pathologically proven advanced esophageal cancer (Stage II to IV).
(2) Written informed consent is obtained from patient.
(3) Major organs are in normal conditions.
Hemoglobin => 8.0g/dL
White blood cell count 3,000 to 12,000/mm3
Neutrophil count => 1,500/mm3
Platelet count => 80,000/mm3
Serum bilirubin <= 2.0 times upper limit of normal
AST, ALT <= 3.0 times upper limit of normal
Serum creatinine <= 1.4 mg/dL
Key exclusion criteria
(1) Known hypersensitivity to taxanes, platinum, fluoropyrimidines. Known dihydropyrimidine-dehydrogenase (DPD) deficit.
(2) Pre-existing motor or sensory neurotoxicity of a severity => Grade2
(3) Active infectious diseases.
(4) Symptomatic bleeding tendency, coagulation disorder, or coagulation factor deficiency.
(5) Uncontrollable hypertension, uncontrollable diabetes, unstable angina, or heart failure.
(6) Pre-existing renal insufficiency or proteinuria => 2+.
(7) Clinical or radiographic signs of interstitial pneumonia or pulmonary fibrosis.
(8) Active gastrointestinal bleeding, bowel obstruction.
(9) Patients who are judged inappropriate for the entry into this study by the investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Arakawa |
Organization
Jikei university school of medicine
Division name
Department of oncology and hematology
Zip code
Address
3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan
TEL
03-3433-1111
yarakawa@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Arakawa |
Organization
Jikei university school of medicine
Division name
Department of oncology and hematology
Zip code
Address
3-19-18 Nishi-shimbashi Minato-Ku Tokyo Japan
TEL
03-3433-1111
Homepage URL
esophagus@jikei.ac.jp
Sponsor or person
Institute
Jikei university school of medicine, department of oncology and hematology, department of gastroenterological surgery
Institute
Department
Personal name
Funding Source
Organization
Jikei university school of medicine, department of oncology and hematology
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
| 2012 | Year | 07 | Month | 11 | 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
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 11 | Day |
Last modified on
| 2016 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009877
