UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Tumor response

Key secondary outcomes

Progression-free and overall survival

Study type

Interventional

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

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

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

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

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

Institute

Koshin Chemical Inc.

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2012

Year

04

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

04

Month

16

Day

Last modified on

2012

Year

04

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009130