UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047881 |
|---|---|
| Receipt number | R000054591 |
| Scientific Title | Feasibility Study of Preoperative DCF Therapy in Esophageal Cancer |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/10/13 19:30:58 |
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Basic information
Public title
Feasibility Study of Preoperative DCF Therapy in Esophageal Cancer
Acronym
FEVER trial
Scientific Title
Feasibility Study of Preoperative DCF Therapy in Esophageal Cancer
Scientific Title:Acronym
FEVER trial
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative chemotherapy for esophageal cancer in DCF therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of febrile neutropenia
Key secondary outcomes
Progression Free Survival
Overall Survival
Objective Response Rate
pathological Complete Response
R0 resection rate
Adverse Event
Suture failure rate
Postoperative pneumonia rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DCF therapy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Endoscopic biopsy of the primary esophageal lesion has been histologically diagnosed as either squamous cell carcinoma or adenosquamous carcinoma
2 Clinical stage T1N1to3M0, T2to3N0to3M0 according to the UICC TNM 8th edition
3 18 years or older
4 Patient can receive initial DCF therapy without dose reduction
5 Performance status is 0 or 1
6 Patient has or not has measurable disease
7 Patients written consent to participate in the study has been obtained
8 Latest laboratory values within 14 days prior to enrollment meet all of the following
White blood cell count more than 3000
Platelet count more than 10
Hemoglobin more than 10.0
Total bilirubin less than 1.5
AST less than 100
ALT less than 100
Serum creatinine less than 1.2
SpO2 more than 95
eGFR more than 60
Key exclusion criteria
1. Patient has multiple cancers
2. Patient has active systemic infection
3. Patients who are not willing to use contraception and pregnant and lactating women
4. Psychosis or psychiatric comorbidities
5. History of hypersensitivity to docetaxelcisplatin or polysorbate 80 ontaining products
6. Patient has severe emphysema or pulmonary fibrosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Kiyota |
Organization
Kobe University hospital
Division name
Cancer center
Zip code
650-0017
Address
7-5-2, kusunoki-cho, chuo-ku, kobe, hyogo
TEL
078-382-5111
nkiyota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Nagatani |
Organization
Kobe University hospital
Division name
Medical oncology and hematology
Zip code
650-0017
Address
7-5-2, kusunoki-cho, chuo-ku, kobe, hyogo
TEL
078-382-5111
Homepage URL
nagatani@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University hospital
Address
7-5-2, kusunoki-cho, chuo-ku, kobe, hyogo
Tel
078-382-6999
kainyu@med.kobe-u.ac.jp
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | 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
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054591
| 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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