Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT00631670
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The purpose of this research study is to determine if Stereotactic Body Radiation Therapy (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5 continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15 Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.

Condition or Disease	Intervention/Treatment	Phase
Spinal Tumors	Radiation: Stereotactic Body Radiation Therapy; Radiation: Stereotactic Body Radiation Therapy	N/A

Detailed Description

This protocol is a study of the use of Stereotactic Body Radiation Therapy (SBRT) for all types of primary or metastatic tumors near the spinal cord. The major goal of this study is to evaluate the efficacy and toxicity of a specific SBRT program in a prospective manner. The main outcome variables in this study are pain and neurologic function.

A major issue in delivering SBRT is the number of treatment sessions. There are advantages and disadvantages to both single and multi treatment programs. In this protocol, patients are offered SBRT with either a single treatment or 25 treatment days. This study is not designed to compare different SBRT schedules. A single treatment program is more convenient and likely to relieve symptoms sooner than a multi-session program. A program with 25 treatments may produce better long-term results. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Treatment Group 15 Gy dose in one stereotactic body radiation treatment	Radiation: Stereotactic Body Radiation Therapy; 15 Gy in one treatment
Experimental: 25 Treatments Group 25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment	Radiation: Stereotactic Body Radiation Therapy; Dose: 70 Gy at 2.8 Gy/treatment

Outcome Measures

Primary Outcome Measures

1. Toxicity [2 yrs]

   Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as "acute" meaning during treatment and "late" meaning several months after treatment ended.

Secondary Outcome Measures

1. Local Control [1 year]

   Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery

2. Neurologic Function [2 years]

   Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.

3. Pain Relief [12 weeks]

   Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.

4. Overall One Year Survival [One year]

   Number of patients alive at one year after treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed consent to participate in this protocol

• Patient of all ages are eligible

• All tumor types are eligible

• Patients with prior spine radiotherapy and/or surgery to the involved area are eligible

• The tumor target must be visible on MRI or CT scan

• Stereotactic Body Radiation Therapy (SBRT) on this protocol may produce a better outcome than conventional radiotherapy

Exclusion Criteria:

• Patients who are likely to have a satisfactory outcome with surgical resection, embolization, or radiofrequency ablation without the addition of radiotherapy

• Tumor size, shape, or location is such that it is not reasonable to think the patient may benefit from SBRT as given in this protocol

• The full extent of the tumor cannot be visualized on MRI or CT scan

• Delaying radiotherapy for the time that it takes to start SBRT may compromise outcome compared to starting conventional radiotherapy immediately

• The patient cannot be positioned reproducibly due to pain or other factors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• University of Florida

Investigators

• Principal Investigator: Robert J Amdur, MD, University of Florida- Radiation Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT00631670
• Other Study ID Numbers: IRB # 404-2005
• First Posted: Mar 10, 2008
• Last Update Posted: Feb 3, 2012
• Last Verified: Jun 1, 2010

• Additional relevant MeSH terms: Spinal Cord Neoplasms; Spinal Neoplasms

Study Results

Participant Flow

Arm/Group Title	Single Treatment Group	25 Treatments Group
Arm/Group Description	15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.	25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
Period Title: Overall Study
STARTED	21	0
COMPLETED	21	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Single Treatment Group	25 Treatments Group	Total
Arm/Group Description	15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.	25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.	Total of all reporting groups
Overall Participants	21	0	21
Age (participants) [Number]
<=18 years	0 0%	0 NaN
Between 18 and 65 years	13 61.9%	13 Infinity
>=65 years	8 38.1%	8 Infinity
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.5 (15.9)	58.5 (15.9)
Gender (participants) [Number]
Female	9 42.9%	9 Infinity
Male	12 57.1%	12 Infinity
Region of Enrollment (participants) [Number]
United States	21 100%	21 Infinity

Outcome Measures

1. Primary Outcome

Title	Toxicity
Description	Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as "acute" meaning during treatment and "late" meaning several months after treatment ended.
Time Frame	2 yrs

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Treatment Group	25 Treatments Group
Arm/Group Description	15 Gy dose in one radiation treatment	25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
Measure Participants	21	0
mild acute toxicity	14 66.7%
moderate acute toxicity	0 0%
severe acute toxicity	0 0%
Late toxicity	0 0%

2. Secondary Outcome

Title	Local Control
Description	Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Treatment Group	25 Treatments Grouop
Arm/Group Description	15 Gy dose in one treatment	25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
Measure Participants	21	0
Measure tumors	25	0
Number [tumors]	24

3. Secondary Outcome

Title	Neurologic Function
Description	Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

6 patients presented with tumor-related deficits before treatment.

Arm/Group Title	Single Treatment Group	25 Treatments Group
Arm/Group Description	15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.	25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
Measure Participants	6	0
improved neurologic function	0 0%
unchanged neurologic function	6 28.6%
worse neurologic function	0 0%

4. Secondary Outcome

Title	Pain Relief
Description	Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Patients who reported pain at baseline

Arm/Group Title	Single Treatment Group	25 Treatments Group
Arm/Group Description	15 Gy dose in one radiation treatment	25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
Measure Participants	14	0
Number [participants]	6 28.6%

5. Secondary Outcome

Title	Overall One Year Survival
Description	Number of patients alive at one year after treatment
Time Frame	One year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Treatment Group	25 Treatments Group
Arm/Group Description	15 Gy dose in one radiation treatment	25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment
Measure Participants	21	0
Number [participants]	5 23.8%

Adverse Events

Time Frame	2 years
Arm/Group Title	Single Treatment Group		25 Treatments Group
Arm/Group Description	15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.		25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.
All Cause Mortality
	Single Treatment Group		25 Treatments Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Single Treatment Group		25 Treatments Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Single Treatment Group		25 Treatments Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/21 (66.7%)		0/0 (NaN)
Gastrointestinal disorders
Grade 1 Nausea	9/21 (42.9%)	9	0/0 (NaN)	9
Grade 2 Pharyngitis	5/21 (23.8%)	5	0/0 (NaN)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.