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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003370
Receipt No. R000004049
Scientific Title Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Date of disclosure of the study information 2010/03/25
Last modified on 2014/06/18

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Basic information
Public title Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Acronym T4/M1LYM DCF PI/II study
Scientific Title Phase I/II study of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Scientific Title:Acronym T4/M1LYM DCF PI/II study
Region
Japan

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

Objectives
Narrative objectives1 to evaluate the safety and efficacy of induction chemotherapy with docetaxel,cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Complete response rate
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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
5-fluorouracil 700mg/m2/day day1-5 civ
cisplatin 70mg/m2/day day1
RT 60Gy/30fr/6w
q2w ,2cycle
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
70 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) radiologist permits curative radiotherapy 60Gy
4) with T4 tumors and/or distant lymph node metastasis (M1LYM)
5) no lymph nodes more distant than
the celiac region in the abdomen/no distant organ metastases
6) no esophagobronchial fistulas/no esophagomediastinal fistulas,
7) Aged 20 to 70 years old
8) ECOG PS of 0 or 1
9) no previous treatment of esophageal cancer without endoscopic resection
10) no previous chemotherapy or radiotherapy against any other malignancies
11) adequate organ functions
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 within three months
8) History of unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema
9) Active bacterial or fungous infection
Target sample size 30

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 0471331111
Email hsatake@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironaga SATAKE,MD
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 078-302-4321
Homepage URL
Email hsatake@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization none
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
2010 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2009 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 01 Month 31 Day
Date trial data considered complete
2015 Year 02 Month 28 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 24 Day
Last modified on
2014 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004049

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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