UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023393 |
|---|---|
| Receipt number | R000025834 |
| Scientific Title | Optimal timing of pegfilgrastim in DCF regimen for advanced esophageal cancer |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2023/08/03 20:05:59 |
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Basic information
Public title
Optimal timing of pegfilgrastim in DCF regimen for advanced esophageal cancer
Acronym
Optimal timing of pegfilgrastim in DCF regimen for advanced esophageal cancer
Scientific Title
Optimal timing of pegfilgrastim in DCF regimen for advanced esophageal cancer
Scientific Title:Acronym
Optimal timing of pegfilgrastim in DCF regimen for advanced esophageal cancer
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 pegfilgrastim prophylaxis on day3 (during administering 5FU) in DCF regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of less than 500/uL of neutrophillic number confirmed after 1st course.
Key secondary outcomes
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
pegfilgrastim:3.6mg(s.c.) on day3 in the first course of DCF regimen.
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 proven squamous cell carcinoma.
2) Diagnosed clinical stage II, III,IV based on the UICC-TNM classification with PET-CT or contrast-enhanced CT, and able to receive DCF regimen.
3)Aged over 20 years old. Male and Female.
4)No prior chemotherapy or radiotherapy against malignancy.
5)ECOG performance status of 0 or 1
6)Able to receive full-dose DCF regimen from fist course as preoperative or induction chemotherapy before CRT.
7)Cases with adequately maintained organ functions and fullfilling the following conditions within 14 days before registration.
leukocyte count >= 4000 and < 12000/uL
neutrophil count >= 1,500/ mm3
hemoglobin level >= 10.0g/ dL
platelet count >= 100,000/mm3
AST and ALT <= 100IU/L
total bilirbin <= 1.5mg/dL
serum creatinine <= 1.5mg/dL
Creatinine clearance >= 60ml/min
8)Written informed consent
Key exclusion criteria
1)Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma
2)Evidence of any other serious disease
3)Active local or systemic infection under treatment
4)History of serious allergic reaction
5)Pulmonary fibrosis or interstitial pneumonitis detected by chest X-ray
6)primary hematologic disease
7)Serious allergic reaction to Docetaxel, cisplatin, 5FU and pegfilgrastim
8)Massive pericardial effusion, pleural effusion or ascites
9)Received radiotherapy within 4 weeks before
10)Received drugs of other clinical tests within 4 weeks before
11)History of receiving pegfilgrastim before
12)Pregnant or lactating female
13)Judged inappropriate by the investigators
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gatroenterology and Hepatology
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ishikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gatroenterology and Hepatology
Zip code
6028566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
iskw-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Gatroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kaji-cho 465, Kamigyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
-
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31646714/
Number of participants that the trial has enrolled
23
Results
The incidence of grade 4 neutropenia was 8.7 percent. No patient experienced FN. Of the 19 patients who received two cycles of DCF, one required a dose reduction/treatment delay due to hematological toxicity in the second treatment cycle. No serious adverse events, considered relevant to pegfilgrastim, were observed.
Results date posted
| 2023 | Year | 08 | Month | 03 | Day |
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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025834
