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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025205
Receipt No. R000019415
Scientific Title Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer
Date of disclosure of the study information 2017/12/07
Last modified on 2016/12/09

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Basic information
Public title Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer
Acronym Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer
Scientific Title Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer
Scientific Title:Acronym Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer
Region
Japan

Condition
Condition locally advanced head and neck cancer
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We compared the pharmacokinetics of S-1 between the initial and reduced dose in patients with locally advanced head and neck cancer.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes comparison of 5-FU AUC SS between the initial and reduced dose of S-1 in the patients
Key secondary outcomes adverse event
tumor reduction rate
overall survival
progression free survival
time to treatment failure


Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction CRT with S-1 plus cisplatin consisted of S-1 (60 mg/m2/day) administered repeated for two weeks orally or via PEG tube twice a day and cisplatin is infused on days 8 through 11 every 5 weeks for 2 courses.
Adjuvant chemotherapy with S-1 plus cisplatin was administered for two more cycles in patients with an objective complete response (CR), good PR (characterized as a secondary change unique to post-CRT that is regarded as residual scar without residual tumor, and defined as lesions < 10 mm in size or not enhancing on contrast-enhanced CT) or PR (partial response) at the first evaluation after CRT.
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 Eligibility required histologically or cytologically confirmed SCCHN with unresectable locally advanced disease. Patients had to meet all of the following inclusion criteria
1. primary lesion located in the nasopharynx, nasal cavity, paranasal sinuses, oropharynx, hypopharynx, larynx, oral cavity, or salivary gland fulfilling at least one of the following the conditions: a) primary lesion or cervical lymph node metastasis to the carotid space (bordering/encasing the artery), skull base, or cervical vertebra and/or its surrounding musculature ; b) T4 primary lesion located in the oropharynx
2. Age between 20 and 75 years
3. ECOG performance status of 0 or 1
4. sufficient organ function
5. normal electrocardiogram.
Key exclusion criteria Exclusion criteria included fistulas, distant metastases, active bacterial or fungal infection; simultaneous or metachronous (within 5 years) second cancers except carcinoma in situ or intramucosal tumor (e.g., gastric or esophageal cancer curable by endoscopic mucosal resection); pregnancy or lactation; active gastrointestinal bleeding; pleural or pericardial effusion; massive ascites; history of severe heart disease, heart failure, myocardial infarction within 6 months, or angina pectoris attack within 6 months; cerebrovascular accident within 6 months; diabetes mellitus treated with insulin or poorly controlled; poorly controlled hypertension; chronic pancreatitis; positive HBs antigen; inability to refrain from smoking and drinking during treatment; and requirement for systemic steroids.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Yamazaki
Organization National Cancer Center Hospital East

Division name Division of Head and Neck Cancer Medical Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa-shi Chiba 277-8577, Japan.
TEL 07-7133-1111
Email tomoppy.and.you26@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Yamazaki
Organization National Cancer Center Hospital East
Division name Division of Head and Neck Cancer Medical Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa-shi Chiba 277-8577, Japan.
TEL 04-7133-1111
Homepage URL
Email tomoppy.and.you26@gmail.com

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization Non profit foundation
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
2017 Year 12 Month 07 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 Completed
Date of protocol fixation
2010 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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
2016 Year 12 Month 09 Day
Last modified on
2016 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019415

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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