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

November 21, 2019 updated by: University of Cincinnati

A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0502
        • University of Cincinnati Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recurrent or second primary squamous cell head and neck cancer
  • Defined area of recurrence on imaging
  • Previous head and neck radiation (RT) to >/= 50 Gy
  • Performance status score 0-1
  • Time interval from previous RT >/= 9 months
  • Volume of disease appropriate for protocol treatment
  • Minimum estimated survival of >/= 3 months
  • Age >/= 18
  • Adequate labs

Exclusion Criteria:

  • Primary tumors of the salivary gland
  • Original pathology report and radiation therapy records not available
  • Prior spinal cord dose > 45 Gy
  • Surgery or chemotherapy within 4 weeks
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel + Stereotactic Radiation
Docetaxel 15mg/m2 IV weekly for 3 weeks. SBRT 25-40 Gy in 5 fractions given twice weekly with each treatment separated by > 48 hours.
Drug: Docetaxel
Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
Other Names:
  • Taxotere
  • NDC 0075-8001-20
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.
Other Names:
  • SBRT
  • Stereotactic Body Radiation
  • Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of acute dose limiting toxicities
Time Frame: 3 months
Acute dose limiting toxicity is defined as grade 4 or 5 toxicity measured by the Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0, including carotid arterial rupture
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional control
Time Frame: 2 years
Time from enrollment until local failure or death (whichever comes first)
2 years
Disease-free survival
Time Frame: 2 years
Time from enrollment until disease progression anywhere in the body or death (whichever comes first)
2 years
overall survival
Time Frame: 2 years
Time from enrollment to death from any cause
2 years
Number of late effect dose limiting toxicities
Time Frame: 2 years
Occuring > 3 months after treatment completion, including grade 4 and 5 toxicities measured by CTCAE v 4.0 involving skin, mucosa, larynx, pharynx, spinal cord, cranial nerves, and incidence of caroid blowout.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: Brad Huth, MD, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

March 29, 2017

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCCI-HN-13-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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