UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033453
Receipt No. R000038145
Scientific Title Clinical study of postoperative adjuvant therapy in locally advanced oral squamous cell carcinoma
Date of disclosure of the study information 2018/07/20
Last modified on 2018/07/19

* 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 study of postoperative adjuvant therapy in locally advanced oral squamous cell carcinoma
Acronym Clinical study of postoperative adjuvant therapy in oral cancer
Scientific Title Clinical study of postoperative adjuvant therapy in locally advanced oral squamous cell carcinoma
Scientific Title:Acronym Clinical study of postoperative adjuvant therapy in oral cancer
Region
Japan

Condition
Condition oral squamous cell carcinoma
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study postoperative adjuvant therapy for locally advanced oral squamous cell carcinoma. By evaluating the usefulness of postoperative adjuvant chemoradiotherapy using concurrent combination of CDDP for high risk of recurrence after oral squamous cell carcinoma surgery, it is possible to reconsider the treatment strategy, and it is necessary to examine therapeutic strategies of oral cancer patients It is considered to be helpful.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5 year Overall survival
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient whose primary tumor is histologically confirmed as oral squamous cell carcinoma.
2. Patient who is the primary case.
3. Patients who underwent radiotherapy or chemoradiotherapy as postoperative adjuvant therapy
Key exclusion criteria 1. Patient who is a local recurrence case
2. Patient other than primary case.
3. In addition, patients whose research managers judged inappropriate as subjects.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Souichi Yanamoto
Organization Nagasaki University
Division name Hospital, Dentistry for Medically Compromised Patient
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7698
Email syana@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Souichi Yanamoto
Organization Nagasaki University
Division name Hospital, Dentistry for Medically Compromised Patient
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7698
Homepage URL
Email syana@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient background: gender, age, primary site, T classification, N classification, clinical stage
Pathological findings: histological differentiation degree, resected stump, pathological extracapsular infiltration
Treatment and prognosis

Management information
Registered date
2018 Year 07 Month 19 Day
Last modified on
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038145

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.