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Adjuvant Hyperfractionated Radiation and Docetaxel for HPV Associated Oropharynx Cancer
NCT01932697Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2013
- Primary completion
- Oct 2016
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Small Molecules
- Drugs
- docetaxel
- Conditions
- oropharyngeal squamous cell carcinoma (OPSCC)
01
Overview
Phase 2, open-label, single-arm trial of docetaxel in oropharyngeal squamous cell carcinoma (OPSCC), sponsored by Mayo Clinic. Primary endpoint: Loco-regional Tumor Control Rate at 2 years. Started Sep 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (docetaxel, hyperfractionated IMRT)
Patients receive docetaxel IV over 1 hour on days 1 and 8 and undergo hyperfractionated IMRT BID 5 days a week on days 1-12 for a total of 20 fractions.
03
Who it enrols
Patients with HPV+ squamous cell carcinoma of the oropharynx who have undergone gross total surgical resection, have a smoking history of < 10 pack-years, ECOG PS 0-1, and specific risk factors.
04
Endpoints
Primary
Loco-regional Tumor Control Rate
Secondary
Incidence of Grade 3 or Higher Mucositis Oral
Overall Survival Rate
Progression-free Survival
Distant Metastasis-free Survival Rate
Change in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile
Functional Assessment of Cancer Therapy Head and Neck
European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35
EuroQol Five-dimensional Instrument
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