UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004555 |
|---|---|
| Receipt number | 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 12:08:43 |
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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
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
Sponsor or person
Institute
Department of Gastroenterologial Surgery,
Graduate School of Medicine,Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005413
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
