Stereotactic Body Radiotherapy for Head and Neck Tumors

• Sponsor: Mercy Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT01344356
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 2
• Duration (Months): 118
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: stereotactic body radiotherapy; Radiation: Stereotactic body radiotherapy	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase IV Trial to Use Stereotactic Body Radiotherapy for Head and Neck Tumors
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Benign Tumors Benign head and neck tumors will be treated with SBRT	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)
Other: Malignant Tumors Malignant Head and Neck Tumors will be treated with SBRT.	Radiation: 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)

Outcome Measures

Primary Outcome Measures

1. Local Control Rate [5 years]

   Complete or partial tumor response or stable disease

2. Local Recurrence [5 years]

   Instances of progressive disease

3. Complication Rate [5 years]

   Number of participants with any adverse event

Secondary Outcome Measures

1. Overall Survival [5 years]

   Number of participants who are alive 5 years following treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. John's Mercy Medical Center	Saint Louis	Missouri	United States	63141

Sponsors and Collaborators

• Mercy Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 4, 2013

More Information

Publications

None provided.

• Responsible Party: Robert Frazier, MD, Physician, Mercy Research
• ClinicalTrials.gov Identifier: NCT01344356
• Other Study ID Numbers: 08-046
• First Posted: Apr 29, 2011
• Last Update Posted: Apr 10, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Robert Frazier, MD, Physician, Mercy Research: stereotactic radiosurgery; head and neck tumors; squamous cell carcinoma of head and neck
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Nasopharyngeal Carcinoma; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms; Chondrosarcoma; Paraganglioma; Chordoma; Head and Neck Neoplasms; Angiofibroma

Study Results

Participant Flow

Arm/Group Title	Benign Tumors	Unrescectable Malignant Tumors
Arm/Group Description	Benign head and neck tumors will be treated with stereotactic body radiation therapy stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)	Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
Period Title: Overall Study
STARTED	1	18
COMPLETED	1	9
NOT COMPLETED	0	9

Baseline Characteristics

Arm/Group Title	Benign Tumors	Unrescectable Malignant Tumors	Total
Arm/Group Description	Benign head and neck tumors will be treated with SBRT 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)	Malignant Head and Neck Tumors will be treated with SBRT. 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)	Total of all reporting groups
Overall Participants	1	18	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	4 22.2%	4 21.1%
>=65 years	1 100%	14 77.8%	15 78.9%
Sex: Female, Male (Count of Participants)
Female	1 100%	2 11.1%	3 15.8%
Male	0 0%	16 88.9%	16 84.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	1 100%	15 83.3%	16 84.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	3 16.7%	3 15.8%
Region of Enrollment (Count of Participants)
United States	1 100%	18 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Local Control Rate
Description	Complete or partial tumor response or stable disease
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Arm/Group Title	Benign Tumors	Malignant Tumors
Arm/Group Description	Benign head and neck tumors will be treated with SBRT 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)	Malignant Head and Neck Tumors will be treated with SBRT. 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)
Measure Participants	1	6
Count of Participants [Participants]	1 100%	5 27.8%

2. Primary Outcome

Title	Local Recurrence
Description	Instances of progressive disease
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.

Arm/Group Title	Benign Tumors	Malignant Tumors
Arm/Group Description	Benign head and neck tumors will be treated with SBRT 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)	Malignant Head and Neck Tumors will be treated with SBRT. 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)
Measure Participants	1	6
Count of Participants [Participants]	0 0%	3 16.7%

3. Primary Outcome

Title	Complication Rate
Description	Number of participants with any adverse event
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

Arm/Group Title	Benign Tumors	Unrescectable Malignant Tumors
Arm/Group Description	Benign head and neck tumors will be treated with Stereotactic body radiotherapy stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)	Malignant Head and Neck Tumors will be treated with Stereotactic body radiotherapy. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
Measure Participants	1	9
Count of Participants [Participants]	1 100%	4 22.2%

4. Secondary Outcome

Title	Overall Survival
Description	Number of participants who are alive 5 years following treatment.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.

Arm/Group Title	Benign Tumors	Malignant Tumors
Arm/Group Description	Benign head and neck tumors will be treated with SBRT 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)	Malignant Head and Neck Tumors will be treated with SBRT. 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)
Measure Participants	0	10
Count of Participants [Participants]	0 0%	2 11.1%

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
Arm/Group Title	Benign Tumors		Malignant Tumors
Arm/Group Description	Benign head and neck tumors will be treated with SBRT stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)		Malignant Head and Neck Tumors will be treated with SBRT. Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
All Cause Mortality
	Benign Tumors		Malignant Tumors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		8/10 (80%)
Serious Adverse Events
	Benign Tumors		Malignant Tumors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	Benign Tumors		Malignant Tumors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/1 (100%)		5/8 (62.5%)
Gastrointestinal disorders
Esophagitis	0/1 (0%)		2/8 (25%)
Mucositis	1/1 (100%)		1/8 (12.5%)
General disorders
Hoarseness	0/1 (0%)		2/8 (25%)
Fatigue	1/1 (100%)		1/8 (12.5%)
Dizziness	1/1 (100%)		0/8 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain	0/1 (0%)		1/8 (12.5%)
Nervous system disorders
Cranial Nerve Neuropathy	1/1 (100%)		0/8 (0%)
Skin and subcutaneous tissue disorders
Alopecia	1/1 (100%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.