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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008400
Receipt No. 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

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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
Email 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
Email esophagus@jikei.ac.jp

Sponsor
Institute Jikei university school of medicine, department of oncology and hematology, department of gastroenterological surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009877

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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