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

Phase 1TerminatedNCT02110992

University of Cincinnati7 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

DocetaxelDRUG

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

Stereotactic RadiationRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Cincinnati Cancer Institute

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

Locoregional control

Time from enrollment until local failure or death (whichever comes first)

Time frame: 2 years

Disease-free survival

Time from enrollment until disease progression anywhere in the body or death (whichever comes first)

Time frame: 2 years

overall survival

Time from enrollment to death from any cause

Time frame: 2 years

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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