At a glance
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DART-HPV: A Phase III Evaluation of De-escalated Adjuvant Radiation Therapy for HPV-Associated Oropharynx Cancer
In Brief
A Phase 3 clinical trial evaluating Adjuvant Radiation Therapy, Docetaxel, and 1 other intervention for Oropharynx Cancer. Completed, enrolled 228 participants across 2 sites.
Detailed Summary
This study is designed for patients with a cancer of the oropharynx (tonsils or base of tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks of daily radiation therapy. This study investigates a less intense radiation treatment following surgery that uses half the dose of radiation given over two weeks rather than six weeks. Patients will be randomly assigned to receive the less intense treatment versus the traditional treatment by coin flip. Patients are twice as likely to receive the less intense treatment during randomization.
Study Details
Timeline
Interventions
60 Gy / 2 Gy fractions (standard arm) 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)
15 mg/m2. Experimental arm only.
40 mg/m2. Standard arm only.