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

Phase 1

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Drug: Docetaxel; Radiation: Stereotactic Radiation

• Registration Number: NCT02110992
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Primary Completion: 2017-03-29
• Study Completion: 2017-03-29
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Docetaxel + Stereotactic Radiation	Docetaxel	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.
Docetaxel + Stereotactic Radiation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
overall survival	2 years	Time from enrollment to death from any cause
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)
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.

Trial Locations

Locations (1)

University of Cincinnati Cancer Institute; 🇺🇸 Cincinnati, Ohio, United States