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Stereotactic Body Radiotherapy for Head and Neck Tumors

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck, Nasopharyngeal Carcinoma, Salivary Gland Cancer

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

stereotactic body radiotherapy

Stereotactic body radiotherapy

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring stereotactic radiosurgery, head and neck tumors, squamous cell carcinoma of head and neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. John's Mercy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Benign Tumors

Malignant Tumors

Arm Description

Benign head and neck tumors will be treated with SBRT

Malignant Head and Neck Tumors will be treated with SBRT.

Outcomes

Primary Outcome Measures

Local Control Rate

Complete or partial tumor response or stable disease

Local Recurrence

Instances of progressive disease

Complication Rate

Number of participants with any adverse event

Secondary Outcome Measures

Overall Survival

Number of participants who are alive 5 years following treatment.

Full Information

NCT ID

NCT01344356

First Posted

April 27, 2011

Last Updated

March 28, 2020

Sponsor

Mercy Research

1. Study Identification

Unique Protocol Identification Number

NCT01344356

Brief Title

Stereotactic Body Radiotherapy for Head and Neck Tumors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mercy Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

stereotactic radiosurgery, head and neck tumors, squamous cell carcinoma of head and neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benign Tumors

Arm Type

Other

Arm Description

Benign head and neck tumors will be treated with SBRT

Arm Title

Malignant Tumors

Arm Type

Other

Arm Description

Malignant Head and Neck Tumors will be treated with SBRT.

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiotherapy

Intervention Description

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)

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body radiotherapy

Intervention Description

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)

Primary Outcome Measure Information:

Title

Local Control Rate

Description

Complete or partial tumor response or stable disease

Time Frame

5 years

Title

Local Recurrence

Description

Instances of progressive disease

Time Frame

5 years

Title

Complication Rate

Description

Number of participants with any adverse event

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Number of participants who are alive 5 years following treatment.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

St. John's Mercy Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

12. IPD Sharing Statement

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Stereotactic Body Radiotherapy for Head and Neck Tumors

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