UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006713 |
|---|---|
| Receipt number | R000007928 |
| Scientific Title | Chronotherapy for oral squamous cell carcinoma -Attempt to reduce side-effects associated with DCF chemotherapy- |
| Date of disclosure of the study information | 2011/11/12 |
| Last modified on | 2021/03/08 12:36:20 |
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Basic information
Public title
Chronotherapy for oral squamous cell carcinoma -Attempt to reduce side-effects associated with DCF chemotherapy-
Acronym
Chronotherapy of DCF chemotherapy
Scientific Title
Chronotherapy for oral squamous cell carcinoma -Attempt to reduce side-effects associated with DCF chemotherapy-
Scientific Title:Acronym
Chronotherapy of DCF chemotherapy
Region
| Japan |
Condition
Condition
oral squamous cell carcinoma
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the adverse effects associated with the docetaxel/cisplatin/5-fluorouracil were reduced by changing dosing-time of day.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Grade 3 or higher neutropenia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Normal Regimen group: Dosing with docetaxel and cisplatin at morning
Interventions/Control_2
2. Chronotherapy regimen group: Dosing with docetaxel and cisplatin at evening
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Stage III, IV an oral squamous cell carcinoma
2. General condition (ECOG Performance Status) is 0-2
3. Satisfy the following criteria within 14 days before registration:
# Leukocyte: 3,000/mm3 <=
# Neutrophil: 2,000/mm3 <=
# Hemoglobin: 10g/dL <=
# Platelet: 100,000/mm3 <=
# AST and ALT: =< 100
# Total Bilirubin: =< 1.5 mg/dL
# Creatinine clearance: 60ml/min <=
Key exclusion criteria
1. Severe hypersensitivity to study drugs
2. With active bacterial and fungal infections
3. Have serious complications (such as chronic obstructive pulmonary disease, pulmonary fibrosis, angina requiring treatment, heart failure)
4. Severe diarrhea
5. Pregnant women or who have a hope of pregnancy
6. Doctor judged unsuitable for participating in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tadahide |
| Middle name | |
| Last name | Noguchi |
Organization
Jichi Medical University
Division name
Department of Oral & Maxillofacial Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7390
tadahide.noguchi@gmail.com
Public contact
Name of contact person
| 1st name | Tadahide |
| Middle name | |
| Last name | Noguchi |
Organization
Jichi Medical University
Division name
Department of Oral & Maxillofacial Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7390
Homepage URL
tadahide.noguchi@gmail.com
Sponsor or person
Institute
Department of Oral & Maxillofacial Surgery, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Research Foundation For Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Review Committee, Jichi Medical University
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
Tel
0285-58-8933
rinri@jichi.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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
9
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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007928
| 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 |
