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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030202

Enrollment

110

Registered

2018-04-01

Start date

2018-04-01

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

Locally advanced Human Papillomavirus-related Oropharyngeal cancer

Interventions

intensity-modulated radiotherapy 2 Gy/fraction/day, 5 fractions/week total doses of 70 Gy/35 fractions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. previously irradiated to the head and neck region 2. active second primary cancer, excluding superficial one 3. T4 and/or N3

Design outcomes

Primary

Measure	Time frame
2-year progression free survival rate	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactNorihiko Takemoto

Osaka University Graduate School of Medicine Deptartment 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