Unique ID issued by UMIN | UMIN000030202 |
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Receipt number | R000034425 |
Scientific Title | Development of De-escalation Therapy for Human Papillomavirus-Related Oropharyngeal Cancer |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2018/12/03 23:12:18 |
Development of De-escalation Therapy for Human Papillomavirus-Related Oropharyngeal Cancer
Development of De-escalation Therapy for Human Papillomavirus-Related Oropharyngeal Cancer
Development of De-escalation Therapy for Human Papillomavirus-Related Oropharyngeal Cancer
Development of De-escalation Therapy for Human Papillomavirus-Related Oropharyngeal Cancer
Japan |
Locally advanced Human Papillomavirus-related Oropharyngeal cancer
Oto-rhino-laryngology |
Malignancy
NO
To validate the efficacy and safety of radiotherapy alone
Others
To explore whether plasma HPV DNA copy number and/or FDG-PET/CT parameter predict prognosis
Confirmatory
Explanatory
Phase II
2-year progression free survival rate
response rate, 2-year overall survival rate, 2-year distant metastasis-free survival rate, 2-year cummulative incidence of locoregional failure, 2-year cummulative incidence of distant failure,adverse event, quality of life
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
intensity-modulated radiotherapy
2 Gy/fraction/day, 5 fractions/week
total doses of 70 Gy/35 fractions
20 | years-old | <= |
Not applicable |
Male and Female
1. biopsy-proven, previously untreated oropharyngeal squamous cell carcinoma
2. p16 positive and HPV16 DNA positive
3. technically resectable stage III/IV without distant metastases (excluding T1N1)
according to TNM classification 7th edition
1. previously irradiated to the head and neck region
2. active second primary cancer, excluding superficial one
3. T4 and/or N3
110
1st name | |
Middle name | |
Last name | Hidenori Inohara |
Osaka University Graduate School of Medicine
Deptartment of Otorhinolaryngology-Head and Neck Surgery
2-2 Yamadaoka, Suita, Osaka, Japan
06-6879-3951
hinohara@ent.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Norihiko Takemoto |
Osaka University Graduate School of Medicine
Deptartment of Otorhinolaryngology-Head and Neck Surgery
2-2 Yamadaoka, Suita, Osaka, Japan
06-6879-3951
http://www.med.osaka-u.ac.jp/pub/ent/
ntakemoto@ent.med.osaka-u.ac.jp
Osaka University
Japan Agency for Medical Research and Development
Japanese Governmental office
NO
大阪大学医学部附属病院(大阪府)
関西医科大学附属病院(大阪府)
大阪医科大学附属病院(大阪府)
琉球大学医学部附属病院(沖縄県)
東北大学病院(宮城県)
京都府立医科大学附属病院(京都府)
大阪国際がんセンター(大阪府)
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Terminated
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2017 | Year | 11 | Month | 30 | Day |
2018 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034425
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