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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001272
Receipt No. R000001500
Scientific Title Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)
Date of disclosure of the study information 2008/07/28
Last modified on 2015/11/17

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Basic information
Public title Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)
Acronym Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)
Scientific Title Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)
Scientific Title:Acronym Phase II trial of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck (JCOG0706)
Region
Japan

Condition
Condition unresectable locally advanced squamous cell carcinoma of the head and neck
Classification by specialty
Gastroenterology Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of chemoradiotherapy concurrent with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes complete clinical remission rate
Key secondary outcomes local progression-free survival, progression-free survival, time to treatment failure, overall survival, proportion of nutritional support-free survival, adverse events

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 Maneuver
Interventions/Control_1 Concurrent chemoradiotherapy with S-1 and cisplatin
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma
2) Primary lesion located at oropharynx, hypopharynx, or larynx
3) Unrespectable locally advanced head and neck cancer
4) No fistula of primary lesion or cervical lymph node metastasis
5) No distant metastasis
6) Aged 20 to 75 years old
7) Performance status of 0 or 1
8) No prior radical surgery for head and neck cancer
9) No prior treatment of chemotherapy, radiation therapy, or endocrine tumor against any other malignancies
10) Adequate organ functions defined as indicated below; (1) WBC >= 4,000 /mm3 , WBC <= 12,000 /mm3, (2) Plt >=100,000 /mm3, (3) Hb >=9.5 g/dL, (4) Ccr >= 60 mL/min, (5) Cr <= 1.2 mg/dL, (6) AST <= 100 IU/L, (7) ALT <= 100 IU/L, (8) T.Bil <= 2.0 mg/dL
11) Normal electrocardiogram
12) Written informed consent
Key exclusion criteria 1) Active bacterial or fungous infection
2) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor.
3) Pregnant or lactating women or women of childbearing potential
4) Active gastrointestinal bleeding
5) Pleural effusion, pericardial effusion, or severe ascites
6) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.
7) Cerebrovascular disease within 6 months
8) Uncontrollable diabetes mellitus or requiring administration of insulin
9) Uncontrollable hypertension
10) Chronic pancreatitis
11) Positive HBs antigen
12) Impossible to refrain from smoking and drinking during treatment
13) Requiring systemic steroids medication
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Fujii
Organization National Hospital Organization Tokyo National Medical Center
Division name Department of otolaryngology
Zip code
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo 152-8902, JAPAN
TEL 03-3411-0111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Tahara
Organization JCOG0706 Coordinating Office
Division name Department of gastrointestinal onclolgy, National Cancer Center Hospital East
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
TEL 04-7133-1111
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
自治医科大学(栃木県)
国立がんセンター東病院(千葉県)
東京女子医科大学(東京都)
国立病院機構東京医療センター(東京都)
神奈川県立がんセンター(神奈川県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
国立病院機構四国がんセンター(愛媛県)

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25781202
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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 Completed
Date of protocol fixation
2008 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2013 Year 07 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
2008 Year 07 Month 28 Day
Last modified on
2015 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001500

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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