UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility of alternate-day chemotherapy with S-1 for adjuvant chemotherapy in elderly patients with locally head and neck cancer
Acronym	Feasibility of alternate-day chemotherapy with S-1 for adjuvant chemotherapy in elderly patients with locally head and neck cancer
Scientific Title	Feasibility of alternate-day chemotherapy with S-1 for adjuvant chemotherapy in elderly patients with locally head and neck cancer
Scientific Title:Acronym	Feasibility of alternate-day chemotherapy with S-1 for adjuvant chemotherapy in elderly patients with locally head and neck cancer
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility and safety of alternate-day chemotherapy with S-1 for adjuvant chemotherapy in elderly patient with locally advanced head and neck cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	feasibility
Key secondary outcomes	safety,progression free survival,overall survival

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	S-1 is administered orally at 80-120mg/body for monday wednesday friday sunday,duplicate for 1 year
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)CR decision within 3 month 2)histologically confirmed squamous cell carcinoma 3)primary lesion is maxillary sinus,oral cabity,oropharynx,hypopharynx,larynx(exclude glottisT3No) 4)pStage3,4A,3B 5initial treatment is CR 6)PS0-1 7)with ability of oral intake 8)suffcient function of important organs a)WBC:3,000/mm3-12,000mm3 b)NEU:over2,000/mm3 c)PLT:over100,000mm3 d)Hb:over9.9g/dl e)T-Bil:under1.5mg/dl f)AST,ALT:under100IU/l g)Ccr:over50mL/min 9)written informed consent
Key exclusion criteria	1)administration contraindication for testing drugs 2)receiving flucytocine,phenytoin,warfarin 3)with infection which need to treat 4)with interstitial pneumonitis 5)with severe complications 6)with diarrhea 7)pregnant or nursing woman or women who like be pregnant and men with partner willing to get pregnant 8)doctor's decision not to be registered to this study
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Middle name Last name kazunori Fujiwara
Organization	Tottori University Hospital
Division name	Division of Otolarygology,Head and Neck Surgery
Zip code
Address	36-1 Nishimati Yonago city
TEL	0859-38-6627
Email	kfujiwa@grape.med.tottori-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name kazunori Fujiwara
Organization	Tottori University Hospital
Division name	Division of Otolarygology,Head and Neck Surgery
Zip code
Address	36-1 Nishimati Yonago city
TEL	0859-38-6627
Homepage URL
Email	kfujiwa@grape.med.tottori-u.ac.jp

Sponsor
Institute	Tottori University Hospital,Division of Otolarygology,Head and Neck 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

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 28 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	Terminated
Date of protocol fixation	2013 Year 11 Month 13 Day
Date of IRB	2013 Year 12 Month 26 Day
Anticipated trial start date	2014 Year 02 Month 03 Day
Last follow-up date	2021 Year 03 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 02 Month 26 Day
Last modified on	2021 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015404