UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015561 |
|---|---|
| Receipt number | R000018079 |
| Scientific Title | A study of the effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) for patients with esophageal cancer who receive DCF therapy. |
| Date of disclosure of the study information | 2014/10/30 |
| Last modified on | 2015/01/19 16:28:22 |
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Basic information
Public title
A study of the effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) for patients with esophageal cancer who receive DCF therapy.
Acronym
A study of the effectiveness of prophylactic G-CSF for patients with esophageal cancer who receive DCF therapy.
Scientific Title
A study of the effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) for patients with esophageal cancer who receive DCF therapy.
Scientific Title:Acronym
A study of the effectiveness of prophylactic G-CSF for patients with esophageal cancer who receive DCF therapy.
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether prophylactic granulocyte colony-stimulating factor (G-CSF) reduce febrile neutropenia for patients with esophageal cancer who receive DCF (Docetaxel, cisplatin and 5-FU) therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
incidence of febrile neutropenia
Key secondary outcomes
incidence of myelosupression, duration of neutropenia, adverse event
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
Subcutaneously injection of 50mcg/m²; Filgrastim as G-CSF by the following dose from day 7 to 13 of DCF 1 kur.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically confirmed esophageal cancer.
2.Patients who receive DCF therapy.
3.ECOG PS0-2.
4.Adequate organ function according to following laboratory values obtained within 14 days before enrolement.
CCr>=60ml/min
T-Bil<=1.5mg/dl
AST&ALT<=100IU/l
Hb>=8g/dl
Plt>=10x10^4/mm3
5.Written informed concent.
Key exclusion criteria
1.G-CSF hypersensitivity.
2.Administration of G-CSF within 6 weeks.
3.Infection within 2 weeks.
4.Past history of chemotherapy or radiation therapy.
5.Patients who are pregnant, lactating, with child-bearing potential.
6.Patients who is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Yamasaki |
Organization
Osaka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka Suita City Osaka
TEL
06-6879-3251
Homepage URL
myamasaki@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University School of Medicine Gastroenterological Surgery
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 30 | 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
| 2014 | Year | 10 | Month | 29 | Day |
Last modified on
| 2015 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018079
| 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 |
