UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the pharmacokinetics between the initial and reduced dose of S-1 in the patients with locally advanced head and neck cancer
Title of the study (Brief title)	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	Tomoko Yamazaki
Organization	National Cancer Center Hospital East
Division name	Division of Head and Neck Cancer Medical Oncology Division
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	Tomoko Yamazaki
Organization	National Cancer Center Hospital East
Division name	Division of Head and Neck Cancer Medical Oncology Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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