UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009628 |
|---|---|
| Receipt number | 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 09:15:52 |
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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 (≥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
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
syana@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oral Oncology, Unit of Translational Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011275
