UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025205 |
|---|---|
| Receipt number | 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 17:37:19 |
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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
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
tomoppy.and.you26@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019415
