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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015561
Receipt No. 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

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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
Email 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
Email myamasaki@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University School of Medicine Gastroenterological Surgery
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018079

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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