Stereotactic Body Radiotherapy for Head and Neck Tumors

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344356
• Other study ID #: 08-046
• Status: Completed
• Phase: Phase 4
• Start date: July 2008
• Est. completion date: May 2018

Study information

• Verified date: March 2020
• Source: Mercy Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the local control rates as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of benign and malignant head and neck tumors.

Description:

This single site, non-randomized, prospective, phase IV study includes 3 patient groups to be treated with SBRT:

• Benign tumors, such as paraganglioma, chordoma, chondrosarcoma, as the sole treatment or to gross residual disease after maximal safe resection

• Malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, after initial external beam radiation (Residual Disease Group)

• Unresectable malignant tumors, such as nasopharynx cancer and squamous cell carcinoma, adenocarcinomas, and sarcomas which are recurrent after prior radiation (Primary RT Group) Data collected will include baseline patient demographics, pathology data, radiation therapy procedure, tumor recurrence data, and toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient age > 18 years

• Zubrod performance status of 0-3

• Benign head and neck tumors such as paragangliomas, chordoma, chondrosarcoma

• Malignant head and neck cancers such as invasive squamous cell carcinoma, adenocarcinoma, nasopharyngeal carcinoma, salivary gland cancers, and sarcoma

• Signed study-specific consent form

Exclusion Criteria:

• Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females

• Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Related Conditions & MeSH terms

• Angiofibroma
• Angiofibroma of Head and Neck
• Carcinoma
• Carcinoma, Squamous Cell
• Chondrosarcoma
• Chondrosarcoma of Head and Neck
• Chordoma
• Chordoma of Head and Neck
• Head and Neck Neoplasms
• Head and Neck Sarcoma
• Nasopharyngeal Carcinoma
• Paraganglioma
• Paraganglioma of Head and Neck
• Salivary Gland Cancer
• Salivary Gland Neoplasms
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Radiation:
• stereotactic body radiotherapy
14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
• Stereotactic body radiotherapy
8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)

Locations

Country	Name	City	State
United States	St. John's Mercy Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control Rate	Complete or partial tumor response or stable disease	5 years
Primary	Local Recurrence	Instances of progressive disease	5 years
Primary	Complication Rate	Number of participants with any adverse event	5 years
Secondary	Overall Survival	Number of participants who are alive 5 years following treatment.	5 years