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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name