UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001272 |
|---|---|
| Receipt number | 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 16:35:47 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001500
