UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 07 Month 19 Day
Date of IRB	2018 Year 08 Month 20 Day
Anticipated trial start date	2018 Year 08 Month 20 Day
Last follow-up date	2020 Year 04 Month 21 Day
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	2021 Year 01 Month 26 Day

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