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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007767
Receipt No. R000009130
Scientific Title A clinical study of gene expression models for predicting response to S-1 in patients with head and neck squamous cell carcinoma
Date of disclosure of the study information 2012/04/16
Last modified on 2012/04/16

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Basic information
Public title A clinical study of gene expression models for predicting response to S-1 in patients with head and neck squamous cell carcinoma
Acronym Development of the prediction model for chemotherapeutic response to S-1 in head and neck cancer.
Scientific Title A clinical study of gene expression models for predicting response to S-1 in patients with head and neck squamous cell carcinoma
Scientific Title:Acronym Development of the prediction model for chemotherapeutic response to S-1 in head and neck cancer.
Region
Japan

Condition
Condition Patients who are suitable for S-1 chemotherapy as a first-line treatment in head and neck squamous cell carcinoma.
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify candidate genes responsible for therapeutic response to S-1 chemotherapy based on mRNA expression profile in patients with head and neck squamous cell carcinoma.
Basic objectives2 Others
Basic objectives -Others To construct a prediction model for chemotherapeutic response to S-1 in head and neck cancer.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Tumor response
Key secondary outcomes Progression-free and overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Collect primary tumor and corresponding normal tissue specimens from patients enrolled in this study.
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 1. Primary squamous cell carcinoma of head and neck
2. New or recurrent case
3. Enable sampling of primary tumor
4. Have evaluable tumor region
5. No previous history of chemotherapy nor radiotherapy
6. Not treated with combined radiotherapy or other anticancer drugs
7. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
8. Adequate organ functions; white blood cell count or WBC, >3,500/mm3, <12,000/mm3; platelet count or Plt, >100,000/mm3; neutrophil count or Neu, >2000/mm3; hemoglobin or Hb >9.0g/dl; total serum bilirubin, 1.5 times of normal range in each institute; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT, 2.5 times of normal range in each institute; creatinine clearance or CCr (or e-GFR), >80ml/minute
9. Adult patients aged 20 years or older
10. Written informed consent obtained
Key exclusion criteria 1. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ
2. Women during pregnancy or breast-feeding
3. Severe mental disease
4. Continuous systemic steroid therapy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Tanzawa
Organization Chiba University
Division name Division of Dentistry and Oral-Maxillofacial Surgery; Department of Clinical Molecular Biology
Zip code
Address 1-8-1, Inohana, Chuoku, Chiba, Japan
TEL 043-226-2138
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Yamagami
Organization Koshin Chemical Inc.
Division name Division of Business Development
Zip code
Address Chiba University Innovation Plaza 204, 1-8-15, Inohana, Chuoku, Chiba, Japan
TEL 043-223-0067
Homepage URL
Email nomura-hitomi@koshin-chem.co.jp

Sponsor
Institute Koshin Chemical Inc.
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
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 鹿児島大学大学院医歯学総合研究科 先進治療科学専攻 顎顔面機能再建学講座 顎顔面疾患制御学分野 (鹿児島県)
久留米大学医学部 歯科口腔医療センター (福岡県)
千葉大学医学部附属病院 歯科・顎・口腔外科 (千葉県)
筑波大学大学院 人間総合科学研究科 疾患制御医学専攻 顎口腔外科学分野 (茨城県)
東海大学医学部 外科学系口腔外科 (神奈川県)
獨協医科大学 口腔外科 (栃木県)
奈良県立医科大学 口腔外科学教室 (奈良県)
日本大学歯学部 口腔外科学教室第1講座 (東京都)
日本大学松戸歯学部 口腔外科学教室 (千葉県)
防衛医科大学校 歯科口腔外科 (埼玉県)
北海道大学 大学院歯学研究科 口腔病態学講座 口腔顎顔面外科学分野 (北海道)
鶴見大学歯学部口腔外科学第二講座 (神奈川県)
島根大学医学部 歯科口腔外科学講座 (島根県)
日本大学医学部 耳鼻咽喉・頭頚部外科学系 歯科口腔外科学分野 (東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 16 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
2009 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 16 Day
Last modified on
2012 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009130

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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