UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of docetaxel/cisplatin/5-fluorouracil combination chemotherapy for advanced esophageal cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuhiro Arakawa
Organization	Jikei university school of medicine
Division name	Department of oncology and hematology
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	Yasuhiro Arakawa
Organization	Jikei university school of medicine
Division name	Department of oncology and hematology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 06 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009877