Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

NCT02110992 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-11-25

No results posted yet for this study

Summary

The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT

RADIATION

Stereotactic Radiation

SBRT will be given over 5 fractions separated by \> 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy.

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Brad Huth, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-03-29
Completion
2017-03-29

Countries

  • United States

Study Locations

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Entities

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 NCT02110992 on ClinicalTrials.gov