UMIN-CTR Clinical Trial

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
Email	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
Email	tadahide.noguchi@gmail.com

Sponsor
Institute	Department of Oral & Maxillofacial Surgery, Jichi Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007928