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 (&#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 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


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

Value
https://center6.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