UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014305 |
|---|---|
| Receipt number | R000016646 |
| Scientific Title | Feasibility study of neoadjuvant chemotherapy with docetaxel/CDGP/5-fluorouracil in resectable esophagus cancer |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2019/05/22 16:36:03 |
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Basic information
Public title
Feasibility study of neoadjuvant chemotherapy with docetaxel/CDGP/5-fluorouracil in resectable esophagus cancer
Acronym
DNF-NAC for resectable esophagus cancer
Scientific Title
Feasibility study of neoadjuvant chemotherapy with docetaxel/CDGP/5-fluorouracil in resectable esophagus cancer
Scientific Title:Acronym
DNF-NAC for resectable esophagus cancer
Region
| Japan |
Condition
Condition
esophagus cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the feasibility and efficacy, we conduct neoadjuvant docetaxel/CDGP/5-FU(DNF)chemotherpy for operable esophagus cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of protocol treatment
Key secondary outcomes
Safety
Progression-free survival
Overall survival
R0 resection rate
Operative morbidity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemotherapy using docetaxel,CDGP,5-FU followed by surgical resection
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven esophageal squamous cell carcinoma.
2) Patients who are going to undergo curative esophagectomy with 2F or 3F lymph node dissection.
3) TNM stage Ib-III
4) Performance status 0-2 ECOG
5) Tolerable function of bone marrow,liver and kidney.
Key exclusion criteria
(1) No prior chemotherapy regimen.
(2) history of drug hypersensitivity.
(3) active concomitant malignancy.
(4) serious complications (severe heart disease, active infection)
(5) pregnant or lactating females.
(6) The investigator considers not suitable for the study.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohnuma |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
S-1,W-16,Sapporo
TEL
011-611-2111
ohnuma@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohnuma |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
S-1,W-16,Sapporo
TEL
011-611-2111
Homepage URL
ohnuma@sapmed.ac.jp
Sponsor or person
Institute
Department of Medical Oncology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Oncology, Sapporo Medical University School of Medicine
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
| 2014 | Year | 06 | Month | 18 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2019 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016646
