UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004707 |
|---|---|
| Receipt number | R000005603 |
| Scientific Title | Randomized controlled trial of neoadjuvant chemotherapy plus surgery versus neoadjuvant chemoradiotherapy plus surgery in patients with clinical stage IIB-III esophageal carcinoma (Subset analyses depending on the REG I expression in the tumor) |
| Date of disclosure of the study information | 2010/12/12 |
| Last modified on | 2013/06/15 14:16:43 |
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Basic information
Public title
Randomized controlled trial of neoadjuvant chemotherapy plus surgery versus neoadjuvant chemoradiotherapy plus surgery in patients with clinical stage IIB-III esophageal carcinoma (Subset analyses depending on the REG I expression in the tumor)
Acronym
Controll trial of neoadjuvant chemotherapy versus chemoradiotherapy in patients with esophageal carcinoma
Scientific Title
Randomized controlled trial of neoadjuvant chemotherapy plus surgery versus neoadjuvant chemoradiotherapy plus surgery in patients with clinical stage IIB-III esophageal carcinoma (Subset analyses depending on the REG I expression in the tumor)
Scientific Title:Acronym
Controll trial of neoadjuvant chemotherapy versus chemoradiotherapy in patients with esophageal carcinoma
Region
| Japan |
Condition
Condition
thoracic esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To determine whether neoadjuvant chemoradiotherapy plus surgery improves outcome in patients with clinical stage IIB-III esophageal carcinoma undergoing neoadjuvant chemotherapy plus surgery. We also performe subset analyses to determine the outcome depending on the REG I expression in the tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
overall survival depending on the REG I expression in the tumor
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
neoadjuvant chemotherapy
Interventions/Control_2
neoadjuvant chemoradiotherapy
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) primary squamous cell carcinoma in the thoracic esophagus
(2) clinical stage IIB-III(Non T4)
(3) ECOG-PS 0,1
(4) Cr<=1.2 mg/dl, BUN<=25 mg/dl, 24hCCr<=60 ml/min, T.Bil<=1.2 mg/dl, GOT and GPT<100 IU, WBC>=4,000 /mm3, Hb>=10 g/dl, Plt>=100,000 /mm3, PaO2>=70 torr
(5 ) obtained an informed consent
Key exclusion criteria
(1) treatment history of chemotherapy or radiotherapy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Motoyama |
Organization
Akita University Graduate School of medicine
Division name
Department of Surgery
Zip code
Address
1-1-1 Hondo, Akita
TEL
018-884-6132
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Sasaki |
Organization
Akita University School of Medicine
Division name
Department of General Affairs
Zip code
Address
1-1-1 Hondo, Akita
TEL
018-884-6008
Homepage URL
Sponsor or person
Institute
The cancer board of esophageal cancer in Akita University Hospital
Institute
Department
Personal name
Funding Source
Organization
Akita University Hospital
Organization
Division
Category of Funding Organization
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
秋田大学病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 11 | Day |
Last modified on
| 2013 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005603
