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

NCT00631670 | Completed Results

• 1 other identifier: IRB # 404-2005
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Tumors

Outcome Measures

Primary Outcomes (1)

• Toxicity

  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.

  2 yrs

Secondary Outcomes (4)

• Local Control

  1 year

• Neurologic Function

  2 years

• Pain Relief

  12 weeks

• Overall One Year Survival

  One year

Study Arms (2)

Single Treatment Group

EXPERIMENTAL

15 Gy dose in one stereotactic body radiation treatment

Radiation: Stereotactic Body Radiation Therapy

25 Treatments Group

EXPERIMENTAL

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

Interventions

Stereotactic Body Radiation Therapy RADIATION

15 Gy in one treatment

Single Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Bridget Fitzgerald, Clinical trials coordinator
• Organization: University of Florida, Dept. of Radiation Oncology

fitzgb@shands.ufl.edu

352-265-0680

Study Officials

• Robert J Amdur, MD

  University of Florida- Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: October 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 3, 2012
• Results First Posted: January 25, 2012

Record last verified: 2010-06

Locations

US (1)