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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02110992

Enrollment

Registered

2014-04-10

Start date

2014-04-30

Completion date

2017-03-29

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

Interventions

DRUGDocetaxel

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

RADIATIONStereotactic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of acute dose limiting toxicities	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

Secondary

Measure	Time frame	Description
Locoregional control	2 years	Time from enrollment until local failure or death (whichever comes first)
Disease-free survival	2 years	Time from enrollment until disease progression anywhere in the body or death (whichever comes first)
overall survival	2 years	Time from enrollment to death from any cause
Number of late effect dose limiting toxicities	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026