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Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer

NCT03416153 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-05-22

Study results available
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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.

Conditions

  • Oropharynx Cancer

Interventions

DRUG

Carboplatin

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

Radiation Therapy

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.

DRUG

Paclitaxel

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.

Sponsors & Collaborators

  • VA Ann Arbor Healthcare System

    collaborator FED

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Michelle Mierzwa, M.D. · University of Michigan Rogel Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2023-05-05
Completion
2025-05-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416153 on ClinicalTrials.gov