UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017634 |
|---|---|
| Receipt number | R000020432 |
| Scientific Title | The role of post-operative cetuximab-based bioradiotherapy in high risk head and neck carcinomas. |
| Date of disclosure of the study information | 2015/05/20 |
| Last modified on | 2016/06/27 14:15:01 |
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Basic information
Public title
The role of post-operative cetuximab-based bioradiotherapy in high risk head and neck carcinomas.
Acronym
Post-operative bioradiotherapy in high risk head and neck carcinomas
Scientific Title
The role of post-operative cetuximab-based bioradiotherapy in high risk head and neck carcinomas.
Scientific Title:Acronym
Post-operative bioradiotherapy in high risk head and neck carcinomas
Region
| Japan |
Condition
Condition
Head and neck squamous cell carcinomas
Classification by specialty
| Hematology and clinical oncology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility and efficacy of cetuximab-based bioradiotherapy in post-operative setting.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of this treatment
Probability of adverse effect
Key secondary outcomes
Overall survival rate
Disease free survival rate
Loco-regional control rate
Probability of distant metastasis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cetuximab-based Bioradiotherapy
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The cases pathologically diagnosed as squamous cell carcinomas
The cases of over than stage 3
The cases with the following risk factors after the surgery
1. tumor cell in surgical margins.
2. Less than 5mm of sugical margin.
3. Extra capsular spread of lymph node metastasis
4. Perineural invasion
5. vessel or ductal invasion, or tumor thrombosis
Key exclusion criteria
The cases with a history of Interstitial pneumonia.
The cases with a history of irradiation on head and neck region.
The cases that researchers regard as inadequate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sakashita |
Organization
Hokkaido University Graduate school of Medicine.
Division name
Department of Otolaryngology- Head and Neck Surgery.
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-707-5958
t-sakashita@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sakashita |
Organization
Hokkaido University Graduate school of Medicine.
Division name
Department of Otolaryngology- Head and Neck Surgery.
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-707-5958
Homepage URL
t-sakashita@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Otolaryngology- Head and Neck Surgery,
Hokkaido University Graduate school of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Department of Otolaryngology- Head and Neck Surgery,
Hokkaido University Graduate school of Medicine.
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 20 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020432
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
