UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009628
Receipt No. R000011275
Scientific Title Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
Date of disclosure of the study information 2012/12/25
Last modified on 2019/07/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
Acronym Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
Scientific Title Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
Scientific Title:Acronym Clinical trial of postoperative chemotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
Region
Japan

Condition
Condition Oral squamous cell carcinoma
Classification by specialty
Hematology and clinical oncology Radiology Oral surgery
Dental medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate both of the efficacy and the safety of postoperative chemoradiotherapy with TS-1 in recurrent high-risk cases with oral squamous cell carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Disease-free survival
Key secondary outcomes 1) Overall survival
2) Relapse-free survival
3) Local relapse-free survival
4) Proportion of treatment completion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Radiotherapy
RT: Fractionated radiation therapy: 66Gy/33Fr
Interventions/Control_2 Alternate-day oral therapy with TS-1 + Radiotherapy
TS-1: 80mg/body alternate-day treatment (4days/week)
RT: Fractionated radiation therapy: 66Gy/33Fr
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Primary lesion located at oral cavity, and histologically proven squamous cell carcinoma
2) Pathological stage III, IVA or IVB (UICC 7th editio)
3) high risk of locoregional recurrence defined as fulfilling one or more of following factors.
i) Microscopically closed resection margin (<5mm)
ii) Extracapsular nodal extension
iii) Multiple cervical lymph node metastases (&#8805;pN2)
4) Within 56 days from surgery
5) No distant metastasis
6) Aged 20 to 80 years old
7) ECOG performance status (PS) of 0 or 1
8) No prior radiation therapy, chemotherapy, nor hormonal therapy
9) Adequate organ functions
10) Written informed consent
Key exclusion criteria 1) Simultaneous or metachronous (within 5 years) double cancers
2) Administration contraindication of TS-1
3) Serious postoperative complications
4) Watery diarrhea
5) One or more of following comorbid disorder
Poor controlled diabetes, poor controlled hypertension, hepatic cirrhosis, hepatic insufficiency, renal failure, interstitial pneumonia, fibroid lung, severe pulmonary emphysema, active infectious disease, heart failure for not more than 6 months, cardiac infarction, severe aberration of electrocardiogram
6) Pleural effusion, pericardiac effusion, or ascites to be drained.
7) Continuous flucytosine, phenytoin, and warfarin potassium treatment
8) Severe drug allergy
9) Psychiatric disease
10) Women during pregnancy, possible pregnancy, or breast-feeding
11) Men with making pregnant
12) Cases judged to be inappropriate by attending physician
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Umeda
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Clinical Oral Oncology, Unit of Translational Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8588, JAPAN
TEL 095-819-7698
Email

Public contact
Name of contact person
1st name
Middle name
Last name Souichi Yanamoto
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Clinical Oral Oncology, Unit of Translational Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8588, JAPAN
TEL 095-819-7698
Homepage URL
Email syana@nagasaki-u.ac.jp

Sponsor
Institute Department of Clinical Oral Oncology, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 九州歯科大学附属病院口腔外科(福岡県)
産業医科大学病院歯科口腔外科(福岡県)
九州大学病院顎口腔外科(福岡県)
九州大学病院顔面口腔外科(福岡県)
佐賀大学医学部付属病院歯科口腔外科(佐賀県)
大分大学医学部付属病院歯科口腔外科(大分県)
長崎大学病院顎・口腔外科顎口腔再外科室(長崎県)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 25 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
2012 Year 12 Month 21 Day
Date of IRB
2012 Year 12 Month 25 Day
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 12 Month 25 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011275

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.