UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009856
Receipt number 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 10:43:21

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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 or person

Institute

National Center for Global health and Medicine
Otolarygology

Institute

Department

Personal name



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

Value
https://center6.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