UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008953 |
|---|---|
| Receipt number | R000009268 |
| Scientific Title | Phase II Study of De-intensified Treatment (radiation alone) for Human Papilloma Virus-Associated Oropharyngeal Cancer |
| Date of disclosure of the study information | 2012/09/20 |
| Last modified on | 2020/06/29 22:01:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II Study of De-intensified Treatment (radiation alone) for Human Papilloma Virus-Associated Oropharyngeal Cancer
Acronym
Radiotherapy for HPV Associated Oropharyngeal Cancer
Scientific Title
Phase II Study of De-intensified Treatment (radiation alone) for Human Papilloma Virus-Associated Oropharyngeal Cancer
Scientific Title:Acronym
Radiotherapy for HPV Associated Oropharyngeal Cancer
Region
| Japan |
Condition
Condition
resectable human papilloma virus associated locally advanced oropharyngeal cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether radiation therapy alone can substitute standard therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
(defined as the proportion of the patients who achieved completer response and/or complete metabolic response)
Key secondary outcomes
2-year overall survival rate, 2-year disease specific survival rate, 2-year recurrence free survival rate, 2-year progression free survival rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
radiation therapy
2-2.2 Gy/fraction/day, 5 fractions/week
total doses of 70-70.4 Gy/32-35 fractions
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. previously untreated oropharyngeal cancer, pathologically diagnosed as squamous cell carcinoma or undifferenciated carcinoma.
2. cases with high risk human papilloma virus, proven from biopsy samples with PCR and with p16 immunopositivity.
3. stage III/IV resectable cases without distant metastases (excluding T1N1cases)
(unsesectable cases are defined as T4b cases of TNM classification (7th edition) or cases with primary tumor or lymph node metastasis fixed with carotid artery, skull base, deep layer of cervial fascia or cervical spine)
4. cases with clinically or radiographically evident measurable lesions
5. cases over 20 years old
6. unimpaired physical condition
i.e. performance status 0-2 (ECOG Score)
7. Hemoglobin levels of 10.0g/dl or above
8. cases expected to survive more than 3 months from the start of the treatment
9. patients with written informed cosent
Key exclusion criteria
1. previously irradiated the same field as currently scheduled
2. presence of active second primary cancer.
heterochronic second primary cancers with no evidence of disease more than 36 months and superficial second primary cancers are allowed.
3. presence of active infectious disease or presence of fever above 38 centidegree
4. cases judged as inappropriate
5. T4 or/and N3
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Inohara |
Organization
Osaka University Graduate School of Medicine
Division name
Dept. of Otorhinolaryngology-Head and Neck Surgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3951
hinohara@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiko |
| Middle name | |
| Last name | Takemoto |
Organization
Osaka University Graduate School of Medicine
Division name
Dept. of Otorhinolaryngology-Head and Neck Surgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3951
Homepage URL
ntakemoto@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Dept. of Otorhinolaryngology-Head and Neck Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine, Dept. of Otorhinolaryngology-Head and Neck Surgery
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
Osaka University Hospital
Address
2-15 yamadaoka Suita Osaka
Tel
06-6879-6090
shiken@hp-crc.med.osaka-u.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
大阪府立成人病センター、大阪府立急性期総合医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 19 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 13 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009268
