Unique ID issued by UMIN | UMIN000035093 |
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Receipt number | R000040005 |
Scientific Title | An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan |
Date of disclosure of the study information | 2018/12/01 |
Last modified on | 2022/01/21 23:13:49 |
An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
An observational study for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
An observational study to optimize first-line treatment for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
An observational study for human papilloma virus-related oropharyngeal carcinoma recorded in the Head and Neck Cancer Registry of Japan
Japan |
HPV related oropharyngeal carcinoma
Oto-rhino-laryngology |
Malignancy
NO
Among patients registered in the multicenter cancer registry of Japan, we will investigate the optimal treatment for human papilloma virus (HPV)-related oropharyngeal carcinoma taking into consideration the survival period and quality of life (QOL) according to clinical stages.
Safety,Efficacy
Overall survival period
Local progression-free survival period
Progression-free survival period
Proportion of nutritional support-free survival
Observational
Not applicable |
Not applicable |
Male and Female
Presence of primary oropharyngeal neoplasm.
The neoplasm is pathologically confirmed as squamous cell carcinoma (SCC).
Histopathologically confirmed 75 % or more of the cancer tissue is p16-positive by immunostaining, irrespective of the assessment time.
Consent to participate in the present trial is obtained at the time of enrollment.
Patients with oropharyngeal cancer registered after 2011 in the multicenter cancer registry of Japan.
History of treatment for head and neck cancer.
Presence of active double cancer (synchronous double cancer, or metachronous double cancer with disease-free period of less than five years. However, lesions corresponding to carcinoma in situ, and mucosal carcinoma judged as cured by localized treatment will not be included as active double cancer)
When the attending physician judges participation in the present study to be unsuitable.
636
1st name | Katsunari |
Middle name | |
Last name | Yane |
Nara Hospital Kindai University Faculty of Medicine
Otorhinolaryngology
630-0293
1248-1 Otoda-cho, Ikoma-shi, Nara prefecture
0743-77-0880
kyane@med.kindai.ac.jp
1st name | Katsunari |
Middle name | |
Last name | Yane |
Nara Hospital Kindai University Faculty of Medicine
Otorhinolaryngology
630-0293
1248-1 Otoda-cho, Ikoma-shi, Nara prefecture
0743-77-0880
kyane@med.kindai.ac.jp
Japan Society for Head and Neck Cancer
Japan Agency for Medical Research and Development
Japanese Governmental office
Kindai University Nara Hospital
1248-1 Otoda-cho, Ikoma-shi, Nara prefecture
0743-77-0880
ikyokujimu@med.kindai.ac.jp
NO
2018 | Year | 12 | Month | 01 | Day |
https://center3.umin.ac.jp/umin-blog/edit/jshnc/?page_id=38#HPV
Published
https://center3.umin.ac.jp/umin-blog/edit/jshnc/?page_id=38#HPV
688
The patients were 558 males and 130 females. The results of the prognosis showed that the new TNM was able to predict prognoses appropriately in both OS and RSF. Findings regarding the treatment methods were as follows, the main method was chemoradiotherapy, and 200 mg.m2 CDDP dose was recommended, with a minimum dose of 160 mg.m2 showing benefit in Stage 1,2. In addition, for the patients having Stage 1,2, the results suggest that even radiotherapy alone can control the disease.
2020 | Year | 06 | Month | 05 | Day |
2020 | Year | 09 | Month | 15 | Day |
The subject sample includes patients with HPV-related oropharyngeal carcinoma who were registered in the multicenter cancer registry of Japan (HNC project) from 2011 onwards. Enrolment of patients already enrolled in other clinical investigations and clinical trials is also permitted.
The final number of registered institutions was 35, and the number of registered patients was 746, which far exceeded the targeted number of 636. After data cleaning, the number of patients became 714; after which patients meeting exclusion criteria, such as those who did not enter previous treatments and those on palliative treatment, were excluded and, ultimately, 688 patients were included in the final analysis set.
none
1.1Primary outcome measure 
Overall survival period
1.2 Secondary outcome measure
Local progression-free survival period, progression-free survival period
Completed
2017 | Year | 07 | Month | 30 | Day |
2017 | Year | 09 | Month | 11 | Day |
2018 | Year | 01 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 12 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 05 | Month | 30 | Day |
For the patient background survey, first line treatment details survey, and prognosis survey, we will access the link only available for members on the Japan Society for Head and Neck Cancer's website, and log into the UMIN INDICE enrollment server with the password.
2018 | Year | 12 | Month | 01 | Day |
2022 | Year | 01 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040005
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