CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 228 enrolled
Drug / intervention
Docetaxel +2 moredrug
Likely dose
Docetaxel 15 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02908477
NCT02908477Phase 3Completed

DART-HPV: A Phase III Evaluation of De-escalated Adjuvant Radiation Therapy for HPV-Associated Oropharynx Cancer

Mayo Clinic·interventional·Posted Sep 21, 2016·Updated Feb 11, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartOct 3, 2016
Primary CompletionAug 20, 2022
Study CompletionNov 15, 2024
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 9.8 years ago

Interventions

Adjuvant Radiation Therapyradiation

60 Gy / 2 Gy fractions (standard arm) 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)

Docetaxeldrug

15 mg/m2. Experimental arm only.

Cisplatindrug

40 mg/m2. Standard arm only.