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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009856
Receipt No. R000011547
Scientific Title To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1
Date of disclosure of the study information 2013/01/24
Last modified on 2013/01/24

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Basic information
Public title To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1
Acronym Phase II of the TS-1 every other day dosing regimen in head and neck cancer
Scientific Title To adjuvant chemotherapy after curative treatment of head and neck cancer A study of alternate-day administration definitive TS-1
Scientific Title:Acronym Phase II of the TS-1 every other day dosing regimen in 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 Consider the accomplishment rate of administration as adjuvant chemotherapy after curative treatment of head and neck cancer, in the alternate-day administration of the granule formulation TS-1.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Completion percentage administration
Key secondary outcomes Adverse event, Total dose for dose planning ,survival, recurrence-free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TS-1 performed in alternate-day dosing
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

Not applicable
Gender Male and Female
Key inclusion criteria Intended for cases corresponding to all of the following items.

1)Cases would be diagnosed with squamous cell carcinoma (except thyroid) primary tumor by histological or cytological diagnosis, curative treatment was performed.In addition, diagnostic imaging(chest X-ray, ultrasound, CT, MRI, such as PET) after two months followed by radiotherapy treatment and surgery (including combination therapy chemoradiation therapy) curative Tumor Free will be confirmed by it is defined as Ru.

2)Maxillary sinus, oral cavity, oropharynx , primary site, larynx (T3N0 glottic excluded) case is it or hypopharynx

3)Cases of IV A , IV B Stage III Stage or clinical or pathological stage

4)Case you do not have anti-cancer treatment until after the end of curative treatment initial registration

5)Patient age at the time of obtaining informed consent is 20 years of age or older

6)0-1 is a case: (PS Performance status) general condition

7)capable of oral intake

8)Patients with the following conditions are met in the bone marrow within 14 days prior to enrollment, liver and renal function

i)WBC:>=3,500/mm3,<12,000/mm3
ii)neutrophil:>=1,500/mm3
iii)blood platelet:>=100,000mm3
iv)hemoglobin:>=9.0g/dL
v)total bilirubin:=2.0mg/dL
vi)AST(GOT):<=100IU/L
ALT(GPT):<=100IU/L
vii)Creatinine clearance:>= case is greater than or equal to 60ml/min
Key exclusion criteria 1)It is contraindicated in patients with the administration of TS-1
2)Cases that are complicated by infection requiring treatment
3)Gastrointestinal disease with treatment (intestinal paralysis, intestinal obstruction, etc.) Patients with
4)Patients with interstitial pneumonitis or pulmonary fibrosis
5)Patients with diabetes
6)Patients with heart disease
7)Patients with (watery) diarrhea
8)Patients attending physician was deemed inappropriate as the subject of the study for other reasons
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nirou Tayama
Organization National Center for Global health and Medicine
Division name Otolarygology
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL 03-3202-7181
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Asakage
Organization Hospital School of Medicine,University of Tokyo
Division name Otolarygology,Auditory speech surgery
Zip code
Address 7-3-1 Hongoh,Bunkyou-ku,Tokyo,Japan
TEL 03-5800-8665
Homepage URL
Email

Sponsor
Institute National Center for Global health and Medicine
Otolarygology
Institute
Department

Funding Source
Organization National Center for Global health and Medicine
Otolarygology
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
2013 Year 01 Month 24 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 No longer recruiting
Date of protocol fixation
2012 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2015 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 24 Day
Last modified on
2013 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011547

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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