UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018108 |
|---|---|
| Receipt number | R000020921 |
| Scientific Title | Feasibility study of planned neck dissection based on tumor HPV status in advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy |
| Date of disclosure of the study information | 2015/06/29 |
| Last modified on | 2020/03/24 18:58:53 |
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Basic information
Public title
Feasibility study of planned neck dissection based on tumor HPV status in advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Acronym
Planned neck dissection in HPV-negative advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Scientific Title
Feasibility study of planned neck dissection based on tumor HPV status in advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Scientific Title:Acronym
Planned neck dissection in HPV-negative advanced oropharyngeal carcinoma receiving concurrent chemoradiotherapy
Region
| Japan |
Condition
Condition
oropharyngeal carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Whether infection of human papillomavirus (HPV) can become the determinative in judging the need of planed neck dissection(PND) after concurrent chemoradiotherapy (CCRT) for the advanced oropharyngeal carcinoma with multple neck lymph node metastasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
neck lymph node recurrence cumulative incidence rate
Key secondary outcomes
overall survival
disease specific survival rate
recurrent free survival rate
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
HPV infection(+): planed neck dissection(-)
Interventions/Control_2
HPV infection(-): planed neck dissection(+)
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. The advanced oropharyngeal cancer patient determined by histopathological or cytologic examination, and has multiple neck lymph metastasis (N2b,N2c,and N3 stage).
2. The patient who agree with detecting HPV infection by p16 immunostaining, the HPV DNA in situ hybridization method, the PCR method.
3. The patient who have a measurable lesion or an evaluable lesion by RECIST.
4. Patient's age is older than 20 years old or younger than 80 years old.
5. The patient who accomplished concurrent chemoradiotherapy as primary treatment.
6. Performance status(ECOG) is 0 or 1.
7. The patient that the function of the main organ (heart, the lungs, the liver, kidney, marrow) maintained normal.
Key exclusion criteria
1. The patient who has severe complications.
2. The patient who has distant metastasis to other organs.
3. The patient who has treated by the radiation therapy to the irradiation part concerned.
4. The patient who have severe drug allergy.
5. The patient who have multiple primary cancer which is impossible to control except head and neck cancer.
6. The woman who has been pregnant or possiblity of pregnancy.
7. The patient who was judged inappropriate target by chief doctor or other doctors concerned with this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mikio |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate school of medicine, university of the Ryukyus.
Division name
Department of otorhinolaryngology, head and neck surgery
Zip code
903-0215
Address
207, Uehara, Nishihara city, Okinawa
TEL
098-895-1183
suzuki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Kinjou |
Organization
University of Ryukyus hospital
Division name
Department of otorhiolaryngology, head and neck surgery
Zip code
903-0215
Address
207, Uehara, Nishihara city, Okinawa
TEL
098-895-1183
Homepage URL
h111853@med.u-ryukyu.ac.jp
Sponsor or person
Institute
Department of otorhinolaryngology, head and neck surgery,Graduate school of medicine, university of the Ryukyus.
Institute
Department
Personal name
Funding Source
Organization
None
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
ethic Committee of Ryukyu university
Address
207 Uehara,Nishihara-cho,Okinawa,903-0215,Japan
Tel
098-895-8016
knknkyu@to.jim.u-ryukyu.ac.jp
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 | 06 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020921
