UMIN-CTR Clinical Trial

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
Email	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
Email	ntakemoto@ent.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Dept. of Otorhinolaryngology-Head and Neck Surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009268