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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004555
Receipt No. R000005413
Scientific Title Randomized study of neoadjvant chemotherapy with FAP versus DCF in patients with resectable Esophageal cancer
Date of disclosure of the study information 2010/11/16
Last modified on 2010/11/15

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Basic information
Public title Randomized study of neoadjvant chemotherapy with FAP versus DCF in patients with resectable Esophageal cancer
Acronym Randomized study of neoadjvant chemotherapy with FAP versus DCF in patients with resectable Esophageal cancer
Scientific Title Randomized study of neoadjvant chemotherapy with FAP versus DCF in patients with resectable Esophageal cancer
Scientific Title:Acronym Randomized study of neoadjvant chemotherapy with FAP versus DCF in patients with resectable Esophageal cancer
Region
Japan

Condition
Condition cT1~T4a esophageal cancers without distant metastasis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate
efficacy and safety of DCF as a neoadjuvant chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes two-year disease free survival rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 chemotherapy FAP
doxorubicin 35 mg/m2/day day1 iv
cisplatin 70 mg/m2/day day1 iv
5-fluorouracil 700 mg/m2/day day1-7 civ
Every 28 days for 2 cycles
After completing treatment, surgical operation is performed.
Interventions/Control_2 chemotherapy DCF
docetaxel 70 mg/m2/day day1 iv
cisplatin 70 mg/m2/day day1 iv
5-fluorouracil 700 mg/m2/day day1-5 civ
Every 21 days for 2 cycles
After completing treatment, surgical operation is performed.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma of the esophagus
2)cT1~4a esophageal cancers without distant metastasis
3)Aged 20 yeara old
4) ECOG PS of 0~2
5) no previous treatment of esophageal cancer
6)adequate organ functions
7) written informed consent
Key exclusion criteria 1)Patients who are unable to tolerate the general anesthesia.
2) Simultaneous or metachronous double cancers
3)with a history of severe allergic reaction against medicines
4) Pregnant or lactating women or women of childbearing potential
5)doctor's decision not to register to this regimen
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichirou Doki
Organization Graduate School of Medicine,Osaka
University
Division name Department of Gastroenterologial Surgery
Zip code
Address 2-2,Yamadaoka,Suita,Osaka,Japan
TEL 06-6879-3251
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Yamasaki
Organization Graduate School of Medicine,Osaka University
Division name Department of Gastroenterologial Surgery
Zip code
Address 2-2,Yamadaoka,Suita,Osaka,Japan
TEL 06-6879-3251
Homepage URL
Email

Sponsor
Institute Department of Gastroenterologial Surgery,
Graduate School of Medicine,Osaka University
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 11 Month 16 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 Open public recruiting
Date of protocol fixation
2010 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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
2010 Year 11 Month 15 Day
Last modified on
2010 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005413

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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