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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000017634 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Head and neck squamous cell carcinomas | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Otolaryngology- Head and Neck Surgery,
Hokkaido University Graduate school of Medicine. |
Institute | |
Department |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020432 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |