UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013279 |
|---|---|
| Receipt number | R000015404 |
| Scientific Title | Feasibility of alternate-day chemotherapy with S-1 for adjuvant chemotherapy in elderly patients with locally head and neck cancer |
| Date of disclosure of the study information | 2014/02/28 |
| Last modified on | 2021/03/03 16:09:27 |
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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
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
kfujiwa@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital,Division of Otolarygology,Head and Neck Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015404
