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

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Stereotactic Radiation
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel + Stereotactic Radiation

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of acute dose limiting toxicities
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

Secondary Outcome Measures

Locoregional control
Time from enrollment until local failure or death (whichever comes first)
Disease-free survival
Time from enrollment until disease progression anywhere in the body or death (whichever comes first)
overall survival
Time from enrollment to death from any cause
Number of late effect dose limiting toxicities
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.

Full Information

First Posted
April 8, 2014
Last Updated
November 21, 2019
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02110992
Brief Title
Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 29, 2017 (Actual)
Study Completion Date
March 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel + Stereotactic Radiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere, NDC 0075-8001-20
Intervention Description
Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Radiation
Other Intervention Name(s)
SBRT, Stereotactic Body Radiation, Radiation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of acute dose limiting toxicities
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Locoregional control
Description
Time from enrollment until local failure or death (whichever comes first)
Time Frame
2 years
Title
Disease-free survival
Description
Time from enrollment until disease progression anywhere in the body or death (whichever comes first)
Time Frame
2 years
Title
overall survival
Description
Time from enrollment to death from any cause
Time Frame
2 years
Title
Number of late effect dose limiting toxicities
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Huth, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Cancer Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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