CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 91 enrolled
Drug / intervention
Carboplatin +2 moredrug
Likely dose
Paclitaxel 30 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/NCT03416153
NCT03416153Phase 2Completed
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A Multi-Center Phase II Trial of Individualized Adaptive De-escalated Radiotherapy Using Pre and Mid-Treatment FDG-PET/CT for HPV-related Oropharynx Cancer

University of Michigan Rogel Cancer Center·interventional·Posted Jan 30, 2018·Updated May 22, 2025

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Radiation Therapy, and 1 other intervention for Oropharynx Cancer. Completed, enrolled 91 participants across 2 sites.

Detailed Summary

This prospective study aims to utilize pre- and mid-treatment PET-CT to guide de-escalation of radiation therapy in HPV-related squamous cell carcinoma of the oropharynx.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOropharynx Cancer
CountriesUnited States
CollaboratorsVA Ann Arbor Healthcare System, National Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 30, 2018
Enrollment StartMay 21, 2018
Primary CompletionMay 5, 2023
Study CompletionMay 5, 2025
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.4 years ago

Interventions

Carboplatindrug

AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.

Radiation Therapyradiation

Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.

Paclitaxeldrug

30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.