Phase II Study of De-intensified Treatment (radiation alone) for Human Papilloma Virus-Associated Oropharyngeal Cancer

Phase II Study of De-intensified Treatment (radiation alone) for Human Papilloma Virus-Associated Oropharyngeal Cancer - Radiotherapy for HPV Associated Oropharyngeal Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008953

Enrollment

Registered

2012-09-20

Start date

2012-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

resectable human papilloma virus associated locally advanced oropharyngeal cancer

Interventions

radiation therapy 2-2.2 Gy/fraction/day, 5 fractions/week total doses of 70-70.4 Gy/32-35 fractions

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
response rate (defined as the proportion of the patients who achieved completer response and/or complete metabolic response)	—

Secondary

Measure	Time frame
2-year overall survival rate, 2-year disease specific survival rate, 2-year recurrence free survival rate, 2-year progression free survival rate	—

Countries

Japan

Contacts

Public ContactNorihiko Takemoto

Osaka University Graduate School of Medicine Dept. of Otorhinolaryngology-Head and Neck Surgery

ntakemoto@ent.med.osaka-u.ac.jp06-6879-3951

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026