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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002396
Receipt No. R000002888
Scientific Title Feasibility trial of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil for clinical stage II/III esophageal carcinoma.
Date of disclosure of the study information 2009/09/01
Last modified on 2011/08/30

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Basic information
Public title Feasibility trial of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil for clinical stage II/III esophageal carcinoma.
Acronym neoadjuvant DCF for esophageal carcinoma
Scientific Title Feasibility trial of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil for clinical stage II/III esophageal carcinoma.
Scientific Title:Acronym neoadjuvant DCF for esophageal carcinoma
Region
Japan

Condition
Condition esophageal neoplasm
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to evaluate the safety and efficacy of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil in patients with clinical stage II/III esophageal carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The rate of treatment completion
Key secondary outcomes Overall survival
Progression free survival
Resectability rate
Adverse event
Response rate

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 initial cohort n=30
aged 70 or younger

docetaxel 70 mg/m2/day day1 iv
cisplatin 70 mg/m2/day day1 iv
5-fluorouracil 750 mg/m2/day day1-5 civ
q3w , 3 cycle
Esophagectomy with D2 (or more) lymph node desection
Interventions/Control_2 expanding cohort n=10
aged 75 or younger

docetaxel 75 mg/m2/day day1 iv
cisplatin 75 mg/m2/day day1 iv
5-fluorouracil 750 mg/m2/day day1-5 civ
q3w , 3 cycle
Esophagectomy with D2 (or more) lymph node desection
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
2) Primary lesion are located within the thoracic esophagus (Te)
3) Clinical stage II or III without T4
4) Aged 20 to 75 years old
(expanding cohort ; aged 75 or younger)
5) ECOG PS of 0 or 1
6) no need for measurable lesion
7) no previous treatment of esophageal cancer
8) no previous chemotherapy or radiotherapy against any other malignancies
9) no palsy of recurrent nerve
10) adequate organ functions
11) curative resection for esophageal carcinoma
12) written informed consent
Key exclusion criteria 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women of childbearing potential
3) Psychosis
4) Patients requiring systemic steroids medication
5) HBs antigen positive
6) Uncontrollable diabetes millutus
7) History of myocardial infarction or unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema
8) Active bacterial or fungous infection
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Tahara, MD, PhD
Organization National Cancer Center Hospital East
Division name Division of Digestive Endoscopy and GI Oncology
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL 04-7133-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hara, MD
Organization Saitama Cancer Center
Division name Department of Gastroenterology
Zip code
Address 818 Komuro, Ina, Saitama 362-0806, Japan
TEL 048-722-1111
Homepage URL
Email hirhara@cancer-c.pref.saitama.jp

Sponsor
Institute Saitama Cancer Center
Institute
Department

Funding Source
Organization Foundation for promotion of cancer research in Japan
Organization
Division
Category of Funding Organization Non profit foundation
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 国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
栃木県立がんセンター(栃木県)
自治医科大学(栃木県)
埼玉県立がんセンター(埼玉県)
大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=102&abstractID=79240
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
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 11 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 08 Month 28 Day
Last modified on
2011 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002888

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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