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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004616
Receipt No. R000005493
Scientific Title A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)
Date of disclosure of the study information 2010/12/01
Last modified on 2020/01/05

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Basic information
Public title A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)
Acronym A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)
Scientific Title A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)
Scientific Title:Acronym A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)
Region
Japan

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

Objectives
Narrative objectives1 The effectiveness and feasibility of preoperative DCF for the resectable advanced esophageal cancer are to be studied comparing those of preoperative FAP in a phase ll randomized trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Recurrence free survival
Key secondary outcomes Rate of R0 resection
Complications of surgery
Overall survival
Adverse events
Response rates

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are stratified by the number of metastatic lymph node and the institute at the registration.
Group A : FAP
CDDP70mg/m2(day1) ADM35mg/m2(day1), and 5-FU700mg/m2(day1-7) following 3 week rest
This treatment is to be done in two courses.
Patients undergo surgical operation (esophageal resection with D2 lymph node dissection) in 3-6 weeks after chemotherapy.
Interventions/Control_2 Group B : DCF
Docetaxel70mg/m2(day1) CDDP70mg/m2(day1), and 5-FU700mg/m2(day1-5) following 2 week rest
This treatment is to be done in two courses.
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.Thoratic esophageal cancer proven squamous cell carcinoma histologically
2.cT1-4a without any distant metastasis (eligible if only with supraclavicular lymph node tumor)
3.patients older than 20 y.o.
4.PS(ECOG) : 0,1 or 2
5.without any prior chemotherapy for esophageal cancer
6.with good organ functions :
WBC : 3,000/mm3 <= and >= 12,000/mm3
Neutrophile : 1,500/mm3 <=
Hemoglobin : 9.0g/dl <=
Platelet : 100,000/mm3 <=
T.bil. : under one and a half time of normal limit
AST,ALT : under two times of normal limit
Creatinine clearance : >=60 (Eligeble in direct method or Cockcroft-Gault method)
SpO2 >= 95% in room air
7.with written Informed Consent
Key exclusion criteria 1.Unresectable due to severe organ dysfunction (brain, heart, lung, liver, and/or kidney)
2.With active double cancers
3.With the history of severe drug allergy
4.Pregnant and/or nursing women, or women who expect to be pregnant
5.Patients whom doctor in chief decides not to register to this study
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichirou Toki
Organization Osaka University Graduate School of Medicine
Division name surgical medicen course
Zip code
Address 2-2-2,Yamadaoka, Suita City, Osaka, Japan 565-0871
TEL 06-6879-3251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Furukawa
Organization Kinki University School of Medicine
Division name Department of surgery
Zip code
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email hiroshi.furukawa@tokushukai.jp

Sponsor
Institute OGSG
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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 大阪大学(大阪府)、近畿大学(大阪府)、大阪成人病センター(大阪府)、大阪医療センター(大阪府)、近畿中央病院(兵庫県)、大阪府立急性期・総合医療センター(大阪府)、関西労災病院(兵庫県)、大阪医科大学(大阪府)、大阪厚生年金病院(大阪府)、NTT西日本大阪病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 01 Day

Related information
URL releasing protocol https://academic.oup.com/annonc/article/28/1/116/2669808
Publication of results Published

Result
URL related to results and publications https://academic.oup.com/annonc/article-abstract/28/1/116/2669808
Number of participants that the trial has enrolled 162
Results
The R0 resection rates for the ACF and DCF groups were equivalent (95.9% versus 96.2%, P?=?0.93). The 2-year RFS and overall survival rates for DCF versus ACF were 64.1% versus 42.9% (hazard ratio 0.53, 95% confidence interval 0.33-0.83, P?=?0.0057) and 78.6% versus 65.4% (P?=?0.08), respectively.
Results date posted
2020 Year 01 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 09 Month 29 Day
Baseline Characteristics
patients with resectable locally advanced esophageal squamous cell carcinoma (ESCC)
Participant flow
Patients with resectable advanced ESCC were randomly assigned to either ACF (Adriamycin 35?mg/m2, cisplatin 70?mg/m2 i.v. on day 1, fluorouracil 700?mg/m2 continuous infusion for 7 days) every 4 weeks or DCF (docetaxel 70?mg/m2, cisplatin 70?mg/m2 i.v. on day 1, fluorouracil 700?mg/m2 continuous infusion for 5 days) every 3 weeks.Surgery was scheduled after completion of two cycles of chemotherapy. 
81 people in each group
Adverse events
.
Outcome measures
The  primary  end  point  was  recurrence-free  survival  (RFS).  Secondaryend  points  were  OS,  the  R0  resection  rate,  histopathological  responserate,  postoperative  complications,  and  safety.  
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 29 Day
Last follow-up date
2014 Year 10 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 12 Month 27 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 24 Day
Last modified on
2020 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005493

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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