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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02110992
• Other study ID #: UCCI-HN-13-001
• Status: Terminated
• Phase: Phase 1
• Start date: April 2014
• Est. completion date: March 29, 2017

Study information

• Verified date: November 2019
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

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.

Locations

Country	Name	City	State
United States	University of Cincinnati Cancer Institute	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	Locoregional control	Time from enrollment until local failure or death (whichever comes first)	2 years
Secondary	Disease-free survival	Time from enrollment until disease progression anywhere in the body or death (whichever comes first)	2 years
Secondary	overall survival	Time from enrollment to death from any cause	2 years
Secondary	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.	2 years